This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
The Medical Device Single Audit Program (MDSAP) is an initiative by the International Medical Device Regulators Forum (IMDRF) to develop a harmonized audit program that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions. The MDSAP pilot program began in 2014 and involves regulators from the US, Canada, Brazil, Australia and Japan. It aims to recognize third-party auditing organizations to conduct audits of medical device manufacturers according to a standardized audit process, with the goal of facilitating medical device trade while ensuring public health and safety.
The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
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.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
[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
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
The Medical Device Single Audit Program (MDSAP) is an initiative by the International Medical Device Regulators Forum (IMDRF) to develop a harmonized audit program that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions. The MDSAP pilot program began in 2014 and involves regulators from the US, Canada, Brazil, Australia and Japan. It aims to recognize third-party auditing organizations to conduct audits of medical device manufacturers according to a standardized audit process, with the goal of facilitating medical device trade while ensuring public health and safety.
The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
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.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
[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
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
ISO 13485 certification ensures the quality and safety of medical devices by requiring companies to follow an international quality management standard. It helps companies attract more contracts by providing a globally recognized guarantee of their medical device products and quality systems. URS Group is an accredited certification body that provides ISO 13485 certification and other services to assess organizations' management systems, audits, trainings, and product certification on a global scale. They are a reputable choice for ISO 13485 certification due to their international accreditation and worldwide network.
Difference between fda 21 cfr part 820 and ISO 13485Anil Chaudhari
The document compares FDA 21 CFR Part 820 and ISO 13485 quality management standards. ISO 13485 is an international voluntary standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and services that consistently meet regulatory requirements. In contrast, FDA 21 CFR Part 820 outlines current good manufacturing practice regulations in the US that govern the design, manufacture, and distribution of medical devices to ensure safety and effectiveness. Key differences include ISO 13485 being a global voluntary standard while FDA 21 CFR Part 820 is mandatory for medical device manufacturers selling products in the US.
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
The document provides an overview of key differences between ISO 13485:2016 and ISO 9001:2015 quality management standards for medical devices. ISO 13485 focuses specifically on safety and regulatory requirements for medical devices, while ISO 9001 takes a more general risk-based approach. Some key differences highlighted include ISO 13485 retaining its requirement for documented procedures and a management representative, while ISO 9001 no longer requires these. The document also provides more detail on specific ISO 13485 clauses such as management review, document control, and feedback.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
This document provides an overview of the key changes between ISO 13485:2003 and ISO 13485:2016 for quality management systems in the medical device industry. It discusses definitions, the timeline for transition, and what is new in each section of the updated standard, including expanded requirements for design and development, purchasing, production, and complaint handling. The changes are aimed at increasing risk-based approaches and ensuring continued compliance with evolving regulations.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
This document summarizes ISO 13485:2016, which outlines requirements for quality management systems for organizations involved in the design, development, manufacturing, installation, or servicing of medical devices. It contains 8 clauses that address the scope, documentation requirements, management responsibilities, and other criteria for quality management processes. Organizations that meet the ISO 13485 standard can receive certification to demonstrate their commitment to quality in the medical device industry.
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
ISO: 14971 Quality risk management of medical devicesAtul Bhombe
This document summarizes ISO 14971, the international standard for medical device risk management. It outlines the key aspects of ISO 14971, including the purpose to help manufacturers identify hazards, estimate risks, and implement risk controls. The summary explains the main clauses of ISO 14971 and the overall risk management process of identifying hazards, estimating risks, evaluating and controlling risks, and monitoring risk controls.
Process Validation & Verification (V&V) for Medical DevicesRina Nir
This document is a presentation on process validation and verification. It discusses six focus areas for ensuring a consistent and controlled process from prototype to finished product: getting CEO commitment, establishing an interdisciplinary team, starting early in product development, knowing suppliers and subcontractors, mapping processes, and understanding sources of variability. It provides examples and advice for each area, such as creating a multidisciplinary team to understand all factors that could affect variability, developing a quality agreement with suppliers, and process mapping to get consensus on how processes are actually performed. The overarching message is that effective process validation requires a holistic and systematic approach across the entire organization.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
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.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
The document provides an overview of medical device regulations in ASEAN countries. It discusses the ASEAN Medical Device Directive (AMDD), which provides harmonized regulations across ASEAN nations. It outlines the medical device classification system and regulatory registration procedure, including requirements for quality systems and clinical evaluation/investigation. Key aspects covered are the ASEAN Common Submission Dossier Template for product registration and ISO 13485 standards for quality management systems.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
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.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
ISO 13485 certification ensures the quality and safety of medical devices by requiring companies to follow an international quality management standard. It helps companies attract more contracts by providing a globally recognized guarantee of their medical device products and quality systems. URS Group is an accredited certification body that provides ISO 13485 certification and other services to assess organizations' management systems, audits, trainings, and product certification on a global scale. They are a reputable choice for ISO 13485 certification due to their international accreditation and worldwide network.
Difference between fda 21 cfr part 820 and ISO 13485Anil Chaudhari
The document compares FDA 21 CFR Part 820 and ISO 13485 quality management standards. ISO 13485 is an international voluntary standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and services that consistently meet regulatory requirements. In contrast, FDA 21 CFR Part 820 outlines current good manufacturing practice regulations in the US that govern the design, manufacture, and distribution of medical devices to ensure safety and effectiveness. Key differences include ISO 13485 being a global voluntary standard while FDA 21 CFR Part 820 is mandatory for medical device manufacturers selling products in the US.
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
The document provides an overview of key differences between ISO 13485:2016 and ISO 9001:2015 quality management standards for medical devices. ISO 13485 focuses specifically on safety and regulatory requirements for medical devices, while ISO 9001 takes a more general risk-based approach. Some key differences highlighted include ISO 13485 retaining its requirement for documented procedures and a management representative, while ISO 9001 no longer requires these. The document also provides more detail on specific ISO 13485 clauses such as management review, document control, and feedback.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
This document provides an overview of the key changes between ISO 13485:2003 and ISO 13485:2016 for quality management systems in the medical device industry. It discusses definitions, the timeline for transition, and what is new in each section of the updated standard, including expanded requirements for design and development, purchasing, production, and complaint handling. The changes are aimed at increasing risk-based approaches and ensuring continued compliance with evolving regulations.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
This document summarizes ISO 13485:2016, which outlines requirements for quality management systems for organizations involved in the design, development, manufacturing, installation, or servicing of medical devices. It contains 8 clauses that address the scope, documentation requirements, management responsibilities, and other criteria for quality management processes. Organizations that meet the ISO 13485 standard can receive certification to demonstrate their commitment to quality in the medical device industry.
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
ISO: 14971 Quality risk management of medical devicesAtul Bhombe
This document summarizes ISO 14971, the international standard for medical device risk management. It outlines the key aspects of ISO 14971, including the purpose to help manufacturers identify hazards, estimate risks, and implement risk controls. The summary explains the main clauses of ISO 14971 and the overall risk management process of identifying hazards, estimating risks, evaluating and controlling risks, and monitoring risk controls.
Process Validation & Verification (V&V) for Medical DevicesRina Nir
This document is a presentation on process validation and verification. It discusses six focus areas for ensuring a consistent and controlled process from prototype to finished product: getting CEO commitment, establishing an interdisciplinary team, starting early in product development, knowing suppliers and subcontractors, mapping processes, and understanding sources of variability. It provides examples and advice for each area, such as creating a multidisciplinary team to understand all factors that could affect variability, developing a quality agreement with suppliers, and process mapping to get consensus on how processes are actually performed. The overarching message is that effective process validation requires a holistic and systematic approach across the entire organization.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
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.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
The document provides an overview of medical device regulations in ASEAN countries. It discusses the ASEAN Medical Device Directive (AMDD), which provides harmonized regulations across ASEAN nations. It outlines the medical device classification system and regulatory registration procedure, including requirements for quality systems and clinical evaluation/investigation. Key aspects covered are the ASEAN Common Submission Dossier Template for product registration and ISO 13485 standards for quality management systems.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
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.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.
https://mavenprofserv.com/what-is-mdsap/
The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.
https://mavenprofserv.com/what-is-mdsap/
https://mavenprofserv.com/mdsap/
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Medical Device Registration in India_ A Comprehensive Guide.pdfPranshuCorpseed
The dynamic landscape of healthcare, the regulatory framework governing medical devices plays a pivotal role in ensuring the safety, efficacy, and quality of products in the market.
This presentation discusses key aspects of quality management in the pharmaceutical industry. It covers the basic elements of quality assurance and quality control. It also discusses various quality approaches like ISO standards and the objectives of quality management. The key principles of quality management are described, including customer focus, leadership, continual improvement, and risk management. Various quality activities are outlined, such as personnel, equipment, sampling, testing, and stability studies. The presentation provides an overview of quality management systems and regulations.
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The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers TGA's progress on the OTC Business Process Review, including strategies and identified future opportunities
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Presentation: Medical Devices Single Audit Program (MDSAP) Pilot Program
1. Medical Devices Single Audit Program
MDSAP - Overview and Update
Keith M Smith
Senior Adviser and MDSAP Assessor
Quality Audits and Assessments Section
Medical Devices Branch
Medical Devices and Product Quality Division
ARCS Scientific Congress Canberra, August, 2016
2. Objectives
• TGA’s International Programs
• IMDRF MDSAP Model
• MDSAP Pilot
• Audits
• Assessments
• Implementation
• Participation
• Questions
1
3. TGA’s International Programs
• Seeking to collaborate with other Regulators in innovative ways
– Share resources and the regulatory work
– Leverage external resources and systems
– Converge requirements and expectations
– Build consistency and confidence in outcomes
• The MDSAP is a significant international program! … we envisage …
– Benefits manufacturers through a reduced number of audits, reduced annual cost, an increase
in the predictability of outcomes, and opportunities for export markets.
– Benefits Sponsors as an additional basis for market authorisation. (ARTG entry)
– Benefits Regulators as it frees resources to target risk areas
2
5. MDSAP model
• Allows recognized Auditing Organisations to conduct audits of a medical device
manufacturer that will satisfy the relevant Quality Management System
requirements of multiple participating Regulatory Authorities.
• Referred to as a “single” audit program
• Started development in 2012 by the International Medical Device Regulators
Forum (IMDRF)
– Successor of the Global Harmonisation Task Force
– Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States of America
4
8. MDSAP Pilot
• International consortium of some of the countries who are members of the IMDRF
who are dedicated to pooling technology, resources, and services to improve the
safety and oversight of medical devices on an international scale in an Audit and
Assessment Pilot Program
– Memorandum of Understanding, Brazil, November 2012
• MDSAP Pilot
– January 2014 – December 2016
7
9. MDSAP Pilot - International Consortium
• MDSAP international consortium of countries:
– Therapeutic Goods Administration (TGA) of Australia,
– Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA),
– Health Canada,
– Japanese MHLW and PMDA, and
– U.S. Food and Drug Administration (US FDA)
• Observers
– World Health Organisation (WHO) Diagnostic Prequalification Program
– European Union
May make a decision about full participation later in 2016
8
10. MDSAP Pilot – Governance and Operations
• Regulatory Authority Council (RAC)
• International Subject Matter Expert (SME) Working Groups
9
11. Regulatory Authority Council (RAC)
• The MDSAP governing body is the RAC
– Two senior managers from each participating jurisdiction
– Representation from observing jurisdictions (WHO and EU)
• Responsibilities:
– Perform executive planning, strategic priorities, sets policy and make final decisions on behalf of
the MDSAP Consortium.
– Final review and approval of MDSAP documentation; policy, procedures, work instructions, etc.
– Auditing Organisation authorisation and recognition decisions
10
12. Subject matter expert (SME) working groups
• MDSAP Audit and Assessment SME
– Develops procedures, work flows, work instructions, templates, training, etc. for
The auditing of medical device manufacturers by recognized Auditing Organisations
The assessment of Auditing Organisations by Regulatory Authorities
A Quality Management System for the operation of the MDSAP
• Regulatory Exchange Platform secure (REPs) SME
– Developed IT requirements and specifications for REPsecure
– Overseeing the Cooperative Agreements with the Host Organisation
Pan American Health Organisation (PAHO)
11
14. MDSAP Audit Process: Model and Criteria
• The design of each layer of the MDSAP seeks to define relevant objectives,
processes, competence management requirements and outputs.
• The audit process for medical device manufacturers provides for an efficient and
thorough coverage of each QMS process requirement
– Documented in an “Audit Model” and “Companion Guide”
– Defines a prescribed audit “process” approach
– The sequence of the audit of QMS processes ensures information determined early in the audit
informs the audit of processes later in the audit.
– Annual audits
13
15. MDSAP Audit Process: Model and Criteria
• Each QMS process has objectives and a series of tasks to determine compliance
with ISO13485 and Regulatory requirements.
• Regulatory requirements include, for example:
– Registration of manufacturing sites
– Licensing of medical devices
– Reporting of adverse event and advisory notices (recalls)
– Tracking of specified devices
– Review of technical documentation in the context of audit
14
16. MDSAP audit process: Model and criteria
• An Auditing Organisation’s activities are directed by a number of documents, for
example:
– Audit Model and Companion Guide
– Nonconformity Grading and RA Exchange Form and Guide
– Audit Report Template and Policy / Guide
– Audit Time Calculations
– Post Audit Timeline
– Certification document content
– Notification of manufacturer participation, etc
• Full process is defined in “MDSAP Audit Procedures and Forms”
– Web search “FDA MDSAP Pilot” for the complete listing
15
17. MDSAP audit
model
- Sequence to
audit QMS
processes for
ISO 13485 and
Regulatory
Requirements
RiskManagement
Purchasing
Management
Device Marketing
Authorisation and
Facility Registration
MD Adverse Events
and Advisory Notice
Reporting
Device Marketing
Authorisation and
Facility Registration
Measurement,
Analysis and
Improvement
Design and
Development
Production and
Service Controls
16
18. Nonconformity grading
• GHTF N19 - Nonconformity
Grading System for Regulatory
Purposes
• NCs are assigned a grade, 1 to 5
• Calculated in two steps
– Grading Matrix
– Escalation Rules
No Documented Process, +1
Release of nonconforming medical
device, +1
3 4
1 2
OccurrenceImpact
First Repeat
Indirect
Cl4.1–6.3
Direct
Cl6.4–8.5.3
17
19. Post audit timeline
• 5 Working Day Notification
– Auditing Organisation informs MDSAP Regulatory Authorities of 1 or more Grade 5
Nonconformities, or >2 Grade 4 Nonconformities, or public health threat/fraud
• 15 Calendar Days
– Medical Device manufacturer provides remediation plan
• 30 Calendar Days
– Medical Device manufacturer provides evidence of implementation of remediation actions for
any grade 4 or 5 nonconformities
• 45 or 90 Calendar Days
– Auditing Organisations submits full audit report package
– 45 days in cases where a 5 day notification was required.
18
20. 19
Initial Audit Surveillance Audit Recertification Audit
Special Audit, Unannounced Audit, Regulatory Authority audit
Stage 1
Documentation Review
Stage 2
On-Site Full Audit
Stage 1 – (as needed)
Documentation Review
Review of changes,
management process,
M,A&I, registration,
authorisation, etc.
Stage 1 – (as needed)
Documentation Review
Review audit reports,
corrections/corrective
actions, tasks not
covered in previous
audits
MDSAP – Manufacturer Audit Program
AuditActivitiesAudit
22. MDSAP Auditing Organisation Assessment Criteria
• An MDSAP Assessment is based on the model established by the IMDRF
MDSAP documents that refer to the relevant ISO Standard, primarily …
– ISO/IEC 17021:2011 – Reqs for bodies providing audit and certification of management systems
– N3 – Requirements for Auditing Organisations
– N5 – Regulatory Authority assessment method
– N11 – Auditing Organisation Nonconformity Grading and Decision Process
– … includes verification that AOs are auditing regulatory requirements
• Full process is defined in “MDSAP Assessment Procedures and Forms”
– Application, Assessment, Decision Making etc.
– Web search “FDA MDSAP Pilot” for the complete listing
21
23. RA assessment method: Processes
Outsourcing
• Management (including Impartiality)
• Measurement, Analysis and Improvement
• Competency Management
• Audit and Certification Process
• Information Management
22
24. 23
MDSAP – Auditing Organisation Assessment Program
Initial Assessment
Application Review
Stage 1 Assessment
including Documentation Review
Stage 2 On-Site Assessment
(Head Office)
3 Witnessed Audits
Surveillance Assessment Re-Recognition Assessment
On-Site Assessment of all
Critical Locations
(as necessary)
Surveillance On-Site
Assessment
(Head Office)
1 Witnessed Audit
1 Witnessed Audit per Critical
Location per Assessment
Cycle (as necessary)
Stage 1 Assessment
including Documentation
Review for changes
Re-Recognition On-Site
Assessment
(Head Office)
1 Witnessed Audit
1 Witnessed Audit per Critical
Location per Assessment
Cycle (as necessary)
AssessmentActivitiesAssessment
25. Summary: Assessment versus audit
Assessment and Recognition
• of Auditing Organisation
by Regulatory Authorities
• of compliance to the IMDRF
Recognition Criteria
– ISO/IEC 17021, IMDRF N3, N5, N11
etc, GHTF N19
• 4-year cycle
• MDSAP Assessment Model
Audits and Certification
• of Medical Device manufacturers
by Auditing Organisation
• of compliance to ISO 13485, plus specific
quality system requirements from the
participating RAs’ regulations
• 3-year cycle
• MDSAP Audit Model
24
28. Auditing organisations and the MDSAP Pilot
• Stages of Assessment
– Application Review
– Stage 1 - Documentation Review
– Stage 2 - Head Office and Critical Location on-site assessments
– When any nonconformities have been closed the AO is “Authorised” to conduct MDSAP audits
under the Pilot arrangements
– 1st MDSAP audit by the AO is witnessed then all assessment material is reviewed to confirm
continued Authorisation.
– A minimum of 2 additional MDSAP audits are to be performed and witnessed to meet the
minimum recognition criteria
– Regulatory Authorities will announce the successful Auditing Organisations at the Pilot and
grant them full MDSAP Auditing Organisation Recognition.
27
30. Auditing organisations and the MDSAP Pilot
• During the Pilot, only the Auditing
Organisations recognized under the
Canadian CMDCAS program were
allowed to participate.
– All 13 have applied and are progressing
through the stages of assessment
– Others will be allowed to apply from 1
January 2017
– See “AO Availability” for an updated listing
on MDSAP website.
• BSI Group America
• TUV SUD America Inc.
• Intertek Testing Services
• LNE G-MED
• SAI Global Certification Services
• TUV USA Inc.
• LRQA
• DQS Med
• DEKRA Certification B.V.
• TUV Rheinland N.A. Inc.
• NSAI
• SGS UK Ltd.
• UL, LLC 29
33. Profile of manufacturers currently participating
• Organisations selling into Canada and internationally
• Manufacturing sites for finished medical devices
• Relatively large organisations
– ~ 70 people and more
• Manufacturers of combination products selling into Australia
• Organisations intending to sell in Brazil
• Manufacturers of high risk medical devices
• Organisations participating in the WHO Prequalification of IVDs Program
32
34. Why should manufacturers participate?
• Limit the number of medical device regulatory audits
• Improvement in predictability of audit outcomes
• Facilitate the application for marketing authorisation in countries where a quality
management system audit is a prerequisite
• Anticipate the transition towards the mandatory application of MDSAP in Canada
• Be a part of the process during the pilot to help shape the policies and procedures
for the operational program scheduled to begin in 2017
• Encourage the Auditing Organisation to get authorized/ recognized
• As MDSAP grows, so will RA participation
• Choice of MDSAP Auditing Organisation
33
35. Some RA-specific benefits
• Australia – TGA will take into account MDSAP audit reports for QMS when:
– deciding whether to issue or maintain Conformity Assessment Certificates that are required for
“combination” products
Medicine / Device, Animal Origin / Device etc.
– auditing applications for ARTG Entry when evidence of compliance with the QMS requirements
of a conformity assessment procedure is required.
– when EC Conformity Assessment Certification for QMS is not available.
• Brazil – program outcomes and reports used as key inputs into ANVISA’s pre-
market and post-market assessment procedures
34
36. Some RA-specific benefits
• Canada – will accept either MDSAP or CMDCAS certificates for obtaining Class
II, III or IV medical device license. Full transition to MDSAP expected to occur by
2019
• Japan – may accelerate the Marketing Authorisation and reduce post-market
burden (still under evaluation)
• United States – will accept MDSAP audit reports as substitute for routine
inspections
• See also MDSAP Question and Answer document on FDA MDSAP website!
35
37. WHO Prequalification for diagnostic devices
• MDSAP audits may be recognized as acceptable evidence of QMS compliance
with international regulations, resulting in an abbreviated or waived site audit
by WHO.
36
38. How to participate
• Any medical device manufacturer is eligible
• Participation is not initiated through a Regulatory Authority!
• Identify a participating MDSAP Auditing Organisation - FDA MDSAP website.
– Any current CMDCAS recognized registrar
– Many may also be able to provide audit and assessment for EC Certification.
• Inquire if the AO has progressed sufficiently in the assessment process to accept
applications for an MDSAP audit.
• An RA’s routine audit / inspection program will not be suspended until an AO
notifies MDSAP of a manufacturer’s participation in the program.
– Note that “for cause” audits may still be conducted by RAs
37
When a manufacturer elects to participate in MDSAP, they agree to a 3 year audit cycle. The audit cycle begins in the first year with the initial audit (certification), which is comprised of a Stage 1 documentation review to verify that all documents required under ISO 13485 and RA regulations are present. An on-site Stage 2 audit is the second part of the initial audit. For the Stage 2, auditors verify implementation of requirements and records.
For Years 2-3 of the audit cycle two Surveillance audits must be conducted. An individual surveillance audit does not need to cover all MDSAP requirements, but must address Clause 9.3.2.1 of ISO 17021 and:
Changes to products, QMS or manufacturer changes
Audit tasks associated with: the management process; adverse event and advisory notice reporting; device marketing authorisation and facility registration; and design and development or production and service controls
Recertification Audits
Do not require a Stage 1, unless significant changes have occurred since last audit
Can be shorter than the initial audit through more selection and focused sampling
Audit should include:
Review of MDSAP audit reports
Changes to manufacturer/QMS
Follow-up on any corrections/corrective actions from previous findings
Review of the QMS effectiveness/suitability over the current audit cycle
All other applicable MDSAP audit process tasks
Special, Unannounced or RA audits can occur at any time during the MDSAP audit cycle