During this presentation we will explore where Medical Device Risk Management Systems are today. We will look at the quickly upcoming deadlines for implementing the ISO 14971:2019 3rd Edition, and EN ISO 14971:2019/A11:2021 standards. We will also mention the potential next (4th) edition of ISO 14971, and how the industry may influence the next edition.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
EU CTR Compliance and Success Navigating Updates and Preparing Submissions fo...MMS Holdings
As of January 31, 2023, Sponsors are required to submit all new trial applications for authorization in the European Union through the Clinical Trial Information System (CTIS) in compliance with the new European Union Clinical Trials Regulation (EU CTR). With the new regulation, Sponsors are seeking guidance with questions such as: what types of documents to include, processes, timelines, and how to protect confidential information, among others. Not fully understanding the process could result in releasing unprotected data or withdrawing the application due to unmet deadlines and requirements.
https://info.mmsholdings.com/eu-ctr-compliance-success-updates-submissions-for-eu-ctis-portal
A comprehensive description of the new requirements introduced by ISO 14971:2019 Application of risk management to medical devices and ISO/TR 24971 Technical Report for the FDA, MDR and IVDR
Electrical Equipment in Medical PracticeNorthwest EMC
Steve Hayes, General Manager of Element Materials Technology, reviews the IEC 60601-1 Series of Medical Equipment Standards.
Learn more at:
http://www.nwemc.com/news/2016/07/07/medical-emc-%E2%80%93-details-of-iec-60601-1-22014-edition-4
EU CTR Compliance and Success Navigating Updates and Preparing Submissions fo...MMS Holdings
As of January 31, 2023, Sponsors are required to submit all new trial applications for authorization in the European Union through the Clinical Trial Information System (CTIS) in compliance with the new European Union Clinical Trials Regulation (EU CTR). With the new regulation, Sponsors are seeking guidance with questions such as: what types of documents to include, processes, timelines, and how to protect confidential information, among others. Not fully understanding the process could result in releasing unprotected data or withdrawing the application due to unmet deadlines and requirements.
https://info.mmsholdings.com/eu-ctr-compliance-success-updates-submissions-for-eu-ctis-portal
A comprehensive description of the new requirements introduced by ISO 14971:2019 Application of risk management to medical devices and ISO/TR 24971 Technical Report for the FDA, MDR and IVDR
Electrical Equipment in Medical PracticeNorthwest EMC
Steve Hayes, General Manager of Element Materials Technology, reviews the IEC 60601-1 Series of Medical Equipment Standards.
Learn more at:
http://www.nwemc.com/news/2016/07/07/medical-emc-%E2%80%93-details-of-iec-60601-1-22014-edition-4
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
European MDR - Understanding Safety and Performance RequirementsKirsten Bertelsen
This presentation is the first of a series of short presentations by medicQA introducing key parts of the new MDR and their impact on medical device manufacturers.
Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALMAligned AG
A concrete example of linking risk management using a preliminary hazard analysis approach with the software architecture when applying IEC 62304 in a medical device ALM.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Greenlight Guru
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
Specifically, you will learn:
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Stan...Greenlight Guru
The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.
The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.
These may include simple reference changes in procedures or revision to production and post-production processes that may be required.
Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard.
TALK TAKEAWAYS:
• A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.
• Reasons for the changes to the latest version
• How to prepare for the coming changes in the standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
ISO/IEC 27001 is the main standard that aims to enhance an organization’s information security.
Amongst others, the webinar covers:
• ISO/IEC 27001 & ISO/IEC 27002, catching up with history
• Quick recap on the ISO/IEC 27002:2022
• From ISO/IEC 27002 to the ISO/IEC 27001 updates
• Some considerations & consequences of the update
• What's up next with ISO/IEC 27001, in practice?
Presenters:
Peter Geelen
Peter Geelen is the director and managing consultant at CyberMinute and Owner of Quest for Security, Belgium. Over more than 20 years, Peter has built strong experience in enterprise security & architecture, Identity & Access management, but also privacy, information & data protection, cyber- and cloud security. Last few years, the focus is on ISO/IEC 27001 and other ISO certification mechanisms. Peter is accredited Lead Auditor for ISO/IEC 27001, ISO 9001, PECB Trainer and Fellow in Privacy. Committed to continuous learning, Peter holds renowned security certificates as certified ISO/IEC 27701 lead implementer and lead auditor, ISO/IEC 27001 Master, Sr. Lead Cybersecurity Manager, ISO/IEC 27002 lead manager, ISO/IEC 27701 Lead Implementer, cDPO, Risk management, Lead Incident Mgr., Disaster Recovery, and many more.
Stefan Mathuvis
Stefan Mathuvis, is owner & senior consultant at Quality Management & Auditing BV, Zonhoven, Belgium. With over 20 years of experience, Stefan built strong experience in quality management systems, Information Security management systems, GDPR, data privacy & data protection. Stefan is accredited ISO/IEC 27001 Lead Auditor and operates as a third party auditor for DQS Belgium. Dividing his time between consultancy, training & third party auditing on an international scale, Stefan remains in touch with the issues of today allowing him to assist clients in their needs for Information Security and Data Privacy.
Date: November 9, 2022
-------------------------------------------------------------------------------
Find out more about ISO training and certification services
Training: https://pecb.com/whitepaper/isoiec-270022022--information-security-cybersecurity-and-privacy-protection
https://pecb.com/article/isoiec-27001---what-are-the-main-changes-in-2022
https://pecb.com/article/investing-in-information-security-awareness
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
-------------------------------------------------------------------------------
For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
European MDR - Understanding Safety and Performance RequirementsKirsten Bertelsen
This presentation is the first of a series of short presentations by medicQA introducing key parts of the new MDR and their impact on medical device manufacturers.
Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALMAligned AG
A concrete example of linking risk management using a preliminary hazard analysis approach with the software architecture when applying IEC 62304 in a medical device ALM.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Greenlight Guru
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
Specifically, you will learn:
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Stan...Greenlight Guru
The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.
The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.
These may include simple reference changes in procedures or revision to production and post-production processes that may be required.
Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard.
TALK TAKEAWAYS:
• A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.
• Reasons for the changes to the latest version
• How to prepare for the coming changes in the standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
ISO/IEC 27001 is the main standard that aims to enhance an organization’s information security.
Amongst others, the webinar covers:
• ISO/IEC 27001 & ISO/IEC 27002, catching up with history
• Quick recap on the ISO/IEC 27002:2022
• From ISO/IEC 27002 to the ISO/IEC 27001 updates
• Some considerations & consequences of the update
• What's up next with ISO/IEC 27001, in practice?
Presenters:
Peter Geelen
Peter Geelen is the director and managing consultant at CyberMinute and Owner of Quest for Security, Belgium. Over more than 20 years, Peter has built strong experience in enterprise security & architecture, Identity & Access management, but also privacy, information & data protection, cyber- and cloud security. Last few years, the focus is on ISO/IEC 27001 and other ISO certification mechanisms. Peter is accredited Lead Auditor for ISO/IEC 27001, ISO 9001, PECB Trainer and Fellow in Privacy. Committed to continuous learning, Peter holds renowned security certificates as certified ISO/IEC 27701 lead implementer and lead auditor, ISO/IEC 27001 Master, Sr. Lead Cybersecurity Manager, ISO/IEC 27002 lead manager, ISO/IEC 27701 Lead Implementer, cDPO, Risk management, Lead Incident Mgr., Disaster Recovery, and many more.
Stefan Mathuvis
Stefan Mathuvis, is owner & senior consultant at Quality Management & Auditing BV, Zonhoven, Belgium. With over 20 years of experience, Stefan built strong experience in quality management systems, Information Security management systems, GDPR, data privacy & data protection. Stefan is accredited ISO/IEC 27001 Lead Auditor and operates as a third party auditor for DQS Belgium. Dividing his time between consultancy, training & third party auditing on an international scale, Stefan remains in touch with the issues of today allowing him to assist clients in their needs for Information Security and Data Privacy.
Date: November 9, 2022
-------------------------------------------------------------------------------
Find out more about ISO training and certification services
Training: https://pecb.com/whitepaper/isoiec-270022022--information-security-cybersecurity-and-privacy-protection
https://pecb.com/article/isoiec-27001---what-are-the-main-changes-in-2022
https://pecb.com/article/investing-in-information-security-awareness
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
-------------------------------------------------------------------------------
For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
ISO/IEC 27005:2022 provides guidance in assisting you and your organization to perform information security risk management activities.
Amongst others, the webinar covers:
• Changes to the ISO/IEC 27005:2022 standard
• Changes to the ISO/IEC 27005:2022 standard
• Why a new ISO/IEC 27005-standard?
Presenters:
Anders Linde
Anders Linde, founder of CISO27, holds more than 12 years of information security consulting and training experience. Anders is particularly interested in resolving the challenges arising from the consolidation and adaptation of international best practices in different organizational settings. Anders is a PECB certified trainer and member of SC27, contributing to the international development of the ISO/IEC 27000 series.
Tony Chebli
Tony is a cybersecurity practice leader and certified instructor. He was appointed as a CISO “information security head” for Group Credit Libanais for the past 13 years.
Tony engineered a security program derived from ISO 27001 and PCI-DSS which helped the Bank comply with Central Bank of Lebanon and Banking Control Commission circulars and satisfy the external and internal IT auditors’ requirements.
He was featured as a keynote speaker at several conferences and contributed to developing security awareness in the Middle East.
Tony was hosted as a speaker for ISC2 Secure Summit in Dubai (November 2017), and the PCI council in Dubai (April 2016), he conducted as well road shows about ISO 27001 in KSA, Dubai, Jordan & Lebanon.
Tony received for three consecutive years the “CISO 100 information security executive” award from the Middle East Security Awards (MESA) in Dubai.
Date: November 16, 2022
Tags: ISO, ISO/IEC 27005, Information Security Risk Management
-------------------------------------------------------------------------------
Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27005
https://pecb.com/article/data-protection-risk-management
https://pecb.com/article/investing-in-information-security-awareness
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
-------------------------------------------------------------------------------
For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
[To download this complete presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO/IEC 27001:2022 is the latest internationally-recognised standard for Information Security Management Systems (ISMS). An ISMS is a systematic approach to managing sensitive company information so that it remains secure. It provides a robust framework to protect information that can be adapted to all types and sizes of organization. Organizations that have significant exposure to information-security related risks are increasingly choosing to implement an ISMS that complies with ISO/IEC 27001.
This ISMS awareness PPT presentation material is designed for organizations who are embarking on ISO/IEC 27001:2022 implementation and need to create awareness of information security among its employees.
LEARNING OBJECTIVES
1. Acquire knowledge on the fundamentals of information security
2. Describe the ISO/IEC 27001:2022 structure
3. Understand the ISO/ IEC 27001:2022 implementation and certification process
4. Gather useful tips on handling an audit session
Tư vấn và đào tạo ISO 27001:2022 phiên bản mới bởi HQC ConsultingNguyễn Đăng Quang
Phiên bản mới của tiêu chuẩn ISO/IEC27001:2022 được ban hành 10.2022.
Các dịch vụ mà HQC Company cung cấp cho quý khách hàng:
- Tư vấn triển khai ISO/IEC27001:2022
- Tư vấn chuyển đổi phiên bản ISO/IEC27001:2022
- Đào tạo Nhận thức ISO/IEC27001:2022
- Đào tạo chuyên gia đánh giá nội bộ ISO/IEC27001:2022
- Đánh giá thử ISO/IEC27001:2022 (pre-adudit)
Liên hệ để lại thông tin được báo giá phù hợp nhất.
Truy cập đường dẫn : https://hqc-company.com/bao-gia-dich-vu-hqc-company/
Hotline: 0777.174.471
CMMC, ISO/IEC 27001, ISO/IEC 27032, and NIST – What You Need to KnowPECB
New data protection regulations have significantly impacted the way that businesses collect, store, and handle clients’ personal information.
Considering the continuously increasing importance of data protection and privacy in today’s world, businesses should be up to speed with their data privacy policies and procedures.
The webinar covers:
1. ISO/IEC 27001 – Information Security Framework Key requirements under CCPA, CPRA, GDPR
• ISO/IEC 27005 – Information Security Risk Management
• ISO/IEC 27035 – Information Security Incident Management
• ISO/IEC 22301 & 27031 - Business Continuity Management (BCM)
2. Alternative Frameworks
• CMMC - Cybersecurity Maturity Model Certification
• NIST CSF Cybersecurity Framework
• ISO/IEC 27032 – Guidelines for Cybersecurity
3. Supplier Management
Date: April 21, 2021
Recorded Webinar: https://youtu.be/bi3tvvhGV1s
Risk Analysis of Dutch Healthcare Company Information System using ISO 27001:...Ridwan Fadjar
A slide of my research for `Risk Analysis of Dutch Healthcare Company Information System using ISO 27001:2017, NEN 7510-2 and COBIT 5` which was presented at INCITEST UNIKOM 2019.
Disruptieve omstandigheden, zoals we die vandaag meemaken, kunnen ertoe leiden dat installaties tijdelijk stilgelegd moeten worden. Hoe dit stilleggen aangepakt wordt, kan een zeer grote impact hebben op het weer opgestart krijgen.
In dit webinar schetsen we u een systematisch opgebouwde aanpak om te bepalen wat u moet doen om installaties tijdelijk stil te leggen tegen minimale kosten en risico’s. Bij deze aanpak bekijken we welke de kritische factoren zijn om straks uw installaties weer vlot in bedrijf te nemen. Precies op die kritische factoren dienen bij het stilleggen de gepaste maatregels genomen te worden. En daarbij wordt ook buiten de puur technische aspecten gekeken, zoals de nodige mankracht en competenties, de kennis over de installatie en de milieuaspecten.
We nemen u graag mee in deze aanpak van Stork Asset Management Technology tijdens dit webinar.
Benefits of ISO/IEC TR 17032 for certification of fire safety engineering pro...Dr. Monideep Dey
This document provides a summary of how ISO/IEC TR 17032, Guidelines and examples of a scheme for the certification of processes, can be used for the certification of the fire safety engineering process used to develop a fire protection program. A specific annex (A.8) is included in ISO/IEC TR 17032 defining the use of the technical report for the development of certification schemes for designs based on fire safety engineering.
Similar to Moving up to the State of the Art in Risk Management (20)
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...Greenlight Guru
The medical device industry is doubling down on compliance readiness. This is a significant shift from last year when we saw accelerating product development as the main goal. Ensuring compliance is a requirement for continued success, and most importantly, patient safety. The panelists will discuss the challenges device companies face as they manage compliance throughout the product lifecycle.
How Electronic Data Capture Is Transforming the MedTech IndustryGreenlight Guru
Clinical research is crucial to the life science industry. But did you know that medical device companies require a different approach? In this discussion, our panelists will talk about the challenges of clinical operations for MedTech, the benefits of leveraging MedTech-specific Electronic Data Capture (EDC) systems, the pitfalls of using outdated clinical data collection methods, such as paper, and much more!
The ROI of Shifting Mindset From Compliance to QualityGreenlight Guru
Many MedTech companies focus on compliance without considering the importance of quality. In this session, panelists will dive into the differences between compliance vs. quality, the benefits of shifting mindset towards quality, and tips on how to start embedding quality into your organization.
Leveraging Modern Software Technologies: MedTech’s Best Kept SecretGreenlight Guru
There are several moving pieces that influence a medical device company’s time-to-market and continued success. An often overlooked (yet critical) one is the tools used to manage the product lifecycle. Are your tools working for you or slowing down your success? In this session, panelists will discuss trends from the 2023 survey results, common challenges with disjointed software solutions, the impact of modernizing, and the power of a modern QMS.
Behind the Stats: Expectations vs. Reality of Bringing a Device to MarketGreenlight Guru
Learn about what’s currently impacting the broader medical device industry. Our panelists will kick off the week by going over all the trends, statistics, and themes uncovered from the 2023 MedTech Industry Benchmark Survey. The session will uncover major shifts in industry goals, the use of modern Medtech software tools, major gaps in product lifecycle processes, and more. Discover how you can apply these findings as you make decisions within your organization in 2023 and beyond.
Common Misconceptions on Medical Device Risk & Design ControlsGreenlight Guru
Learn about common misconceptions on medical device risk and design controls.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
QMSR Harmonization: The Future of FDA's Quality Management System RegulationGreenlight Guru
Learn about the future of FDA's Quality Management System regulation.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Modernizing your QMS to keep up with the Modern Age of RequirementsGreenlight Guru
Learn about the importance of a modern QMS to keep up with changing requirements in the MedTech industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
In this session we will learn about the Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceGreenlight Guru
Understand the FDA's new draft guidance on Computer Software Assurance (CSA).
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...Greenlight Guru
The European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, became effective May 26, 2022. In this session, you’ll get a glimpse of what’s changed since implementation day, the latest guidance available, and ways to keep your IVDD to IVDR transition moving forward.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Reducing Friction Between Companies and Regulatory BodiesGreenlight Guru
We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Latin American Regulations - What you Don't KnowGreenlight Guru
Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Insights on the MedTech Regulatory and Clinical Environment in IsraelGreenlight Guru
Facts about the high-tech industry of Israel
The new medical device law in Israel
The regulatory landscape - requirements and market access
Performing clinical trials in Israel
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
The Global Guide to Human Factors and Usability Engineering RegulationsGreenlight Guru
The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
QMSR Harmonization - The Good the Bad and the UglyGreenlight Guru
Learn about the proposed QMSR rule, intended benefits of MDSAP for the regulatory authorities, benefits for the manufacturer, and similarities between ISO 13485 and FDA Regulations, and more!
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Unique Device Identification —aka UDI— is about more than barcodes and regulatory red tape. This global system for identifying medical devices is a chance to radically improve the quality of life for patients, providers, and producers of medical devices. However, implementing UDI into your product lifecycle means navigating differing requirements in both the United States and the European Union. If you’re looking to go global, we’ve brought together three industry leaders on the subject to make sure you know the difference.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Evaluation of antidepressant activity of clitoris ternatea in animals
Moving up to the State of the Art in Risk Management
1. Moving Up to State of the Art in
Medical Device Risk Management
Edwin Bills, Member ISO TC 210 JWG1
11/1/2022 (c) Edwin Bills Consultant 2022 1
2. Medical Device Risk Management
• Where we are today?
• Where we should be today?
• Where will we be tomorrow?
11/1/2022 (c) Edwin Bills Consultant 2022 2
3. Risk Management is not
a checkbox activity or
just documents to file, it
is a product safety
process.
What if you are the first
patient? How would you
perform risk
management?
Risk Safety
11/1/2022 (c) Edwin Bills Consultant 2022 3
4. Where are we
today?
It is now 11/2022 and
nearly three years after
the release of ISO
14971:2019 3rd edition
11/1/2022 (c) Edwin Bills Consultant 2022 4
5. Where are we today?
• Lots of procedures still point to editions other than
the 2019 edition of ISO 14971
• Procedures still not up to date with requirements,
especially Production and Post-production activities
• Risk Management does not start early enough-
Outputs of Process are Design Inputs (ISO
13485:2016 7.3.3 (c)
11/1/2022 (c) Edwin Bills Consultant 2022 5
6. Where are we today?
• No or Wrong Risk Management Policy
• Many see it as irritating documentation activity
• Product Safety takes a back seat to Schedule and Cost
• Overreliance and misunderstanding of FMEA as a Risk
tool (doesn’t meet all requirements for Risk Analysis)
• Lack of understanding of the process-lack of decision
making skills and good judgement
• Procedures overly complicated
11/1/2022 (c) Edwin Bills Consultant 2022 6
7. Where are we today?
• Lack of statistically valid data to support
quantitative Probabilities of Harm
• Risk Management Plans do not contain Risk
Acceptability Criteria or identify Review Team
• Risk Management File not Traceable
• EC now accepts EN ISO 14971:2019/A11:2021
Harmonised Standard for MDR and IVDR
11/1/2022 (c) Edwin Bills Consultant 2022 7
8. Where are we today?
• Lack of Management support and understanding of risk
management’s importance to success of company
• Many have not yet implemented ISO 14971:2019 and are still
on 2007 or worse EN ISO 14971:2012 (not ISO 14971:2012)
• FDA drops the acceptability of submissions with 2007
edition on December 25, 2022
• 2007 Edition no longer acceptable as of December 2022 as
ISO also drops this standard under 3-year transition
11/1/2022 (c) Edwin Bills Consultant 2022 8
10. Where should we
be?
Time is marching on
and in less than 60 days
we will need to be fully
compliant with ISO
14971:2019
11/1/2022 (c) Edwin Bills Consultant 2022 10
11. Where should we be today?
• ISO 14971:2019 (3rd Edition) was
published in December of 2019
and has been adopted/recognized worldwide
• Required implementation dates vary
– ISO has three year implementation for most standards
• EN ISO 14971:2019/A11:2021 was Harmonised for
the MDR and IVDR (only) in May 2022
• The unamended EN version was recognized as
“state of the art” shortly after publication
11/1/2022 (c) Edwin Bills Consultant 2022 11
12. Where should we be today?
• Given all that background, companies should
have been updating risk management system
documentation to the 3rd edition (ISO or EN
as appropriate)
• Many are not there or not all the way there
• Should have audited RMS and updated
to correct any shortcomings
• Should have audited projects to understand
which Edition to use
11/1/2022 (c) Edwin Bills Consultant 2022 12
13. State of the Art
• In 2020 BSI in their Compliance Monitor
indicated that EN ISO 14971:2019 was the “State of
the Art” medical device risk management process
standard
What is ”state of the art”? Where is it defined?
The only definition is in ISO 14971
11/1/2022 (c) Edwin Bills Consultant 2022 13
14. ISO 14971 Definition
• 3.28 state of the art
• developed stage of technical capability at a given time as
regards products, processes (3.14) and services, based on
the relevant consolidated findings of science, technology and
experience
• Note 1 to entry: The state of the art embodies what is
currently and generally accepted as good practice in
technology and medicine. The state of the art does not
necessarily imply the most technologically advanced solution.
The state of the art described here is sometimes referred to
as the “generally acknowledged state of the art”.
11/1/2022 (c) Edwin Bills Consultant 2022 14
16. ISO TR 24971:2020 Gives a Hint
• Annex G Components and devices designed without
using ISO 14971 can be used as a
guide for updating to latest standard
– First, find the gaps-perform audits, be critical
• Review Policy, procedures, product files
– Second, establish a plan to update
• Responsibilities, dates, criticalities, reviews, projects
– Finally, Monitor progress
• Make changes in plan as required
11/1/2022 (c) Edwin Bills Consultant 2022 16
17. ISO 14971:2019/EN ISO 14971:2019 /A11:2021
Requirements are all the same in all versions of 3rd Edition
• 1 Scope (read the scope-important information)
• 2 Normative references (no normative references)
• 3 Terms and definitions Important to understand terms
• 4 General requirements for risk management system (part of
QMS)
• 5 Risk analysis Most misapplied requirement from misuse of
tools- More than one tool usually required for risk analysis
11/1/2022 (c) Edwin Bills Consultant 2022 17
18. ISO 14971:2019/EN ISO 14971:2019 /A11:2021
• 6 Risk evaluation Must apply Individual Risk Acceptability Criteria
• 7 Risk control Risk Controls are Design Inputs for Safety
Requirements
• 8 Evaluation of overall residual risk Benefit-Risk Analysis (difficult
concept)
• 9 Risk management review (Review of product risk and risk
process leads to Risk Management Report)
• 10 Production and post-production activities (Biggest change to
3rd Ed.)
• Annexes are not requirements of standard, but guidance
11/1/2022 (c) Edwin Bills Consultant 2022 18
19. ISO 14971:2019/EN ISO
14971:2019 /A11:2021
4 General requirements for risk management system
• 4.1 Risk Management Process (Closed Loop process depicted in Figure 1)
• 4.2 Management Responsibilities (Risk Policy, resources, competent
personnel, Risk Management Review [part of QMS Review])
• 4.3 Competence of Personnel (requires documented team of various
disciplines that can provide judgement in decision making)
• 4.4 Risk Management Plan (for each product/product family)
• 4.5 Risk Management File (for each product/product family provides
traceability for all documentation of entire process)
11/1/2022 (c) Edwin Bills Consultant 2022 19
20. ISO 14971:2019/EN ISO
14971:2019 /A11:2021
5 Risk analysis
• 5.1 Risk analysis process (does it comply with 14971?)
• 5.2 Intended use and reasonably foreseeable misuse (need
medical/clinical input and regulatory)
• 5.3 Identification of characteristics related to safety (Annex A
EXAMPLE questions)
• 5.4 Identification of hazards and hazardous situations (Normal
condition & all hazards, not just single fault-here is where FMEA is
weak, need more tools than one. Read this section closely)
• 5.5 Risk estimation (probability of HARM, and Severity of HARM)
11/1/2022 (c) Edwin Bills Consultant 2022 20
21. ISO 14971:2019/EN ISO
14971:2019 /A11:2021
10 Production and post-production activities (Most
changed part of 2019 edition)
• 10.1 General (sets the stage)
• 10.2 Information collection (active process, must go look for
information including internet)
• 10.3 Information review (what is the information telling you about
risk performance of your product?
• 10.4 Actions (Do you need to do anything? What do you need to do?
How urgent is the action needed? Look at both product and risk
management process for issues)
11/1/2022 (c) Edwin Bills Consultant 2022 21
22. ISO 14971:2019/EN ISO 14971:2019
/A11:2021-Move Up to State of the Art
For any product risk management process-
• Start EARLY, should begin by the time of the Design
Plan/Risk Management Plan, maybe even during
concept, and certainly if any clinical trials, that is start
as Risk Analysis required
• Remember, Output of Risk Management is a Design
Input*, establishes Safety Requirements for the product
– * ISO 13485 7.3.3 (c)
11/1/2022 (c) Edwin Bills Consultant 2022 22
23. End of recognition of ISO
14971:2007 is December 2022!
11/1/2022 (c) Edwin Bills Consultant 2022 23
24. Thanks for your attention!
Create a good implementation of medical
device risk management under
ISO 14971:2019 or EN ISO 14971:2019
Amd11:2021
Questions may be
addressed to:
Edwin Bills
elb@edwinbillsconsultant.com
Edwin Bills, Consultant
and Member, ISO TC 210 JWG1
10/28/2022 24
(c)Edwin Bills Consultant 2022
26. References
The Use and Misuse of FMEA in Risk Analysis, Mike Schmidt, Medical Device and Diagnostic Industry,
March 1, 2004, https://www.mddionline.com/testing/use-and-misuse-fmea-risk-analysis , Accessed
Feb 6, 2021
ISO TR 24971:2020 — Bringing Clarity To Risk Acceptability In ISO14971, Med Device Online |
November 19, 2020, Edwin L. Bills, member, ISO TC 210 JWG1
https://www.meddeviceonline.com/doc/iso-tr-bringing-clarity-to-risk-acceptability-in-iso-0001
Closing the Loop on Risk Management ISO 14971, Edwin L. Bills, member, ISO TC 210 JWG1, Med
Device Online, January 22, 2021 https://www.meddeviceonline.com/doc/iso-clarifying-benefit-risk-
benefit-risk-0001
ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk, Edwin L. Bills, member, ISO TC 210
JWG1. Med Device Online, February 8, 2021
https://www.meddeviceonline.com/doc/iso-clarifying-benefit-risk-benefit-risk-0001
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