Risk Management in IES 60601. Medical Devices, Creation and content of RMF, Methods for the visualization and identification of harms and hazards,
Creating a RMF – Minimal Documentation,
Common errors when creating a RMF.
Speed your time to market by following the step-by-step instructions.
You'll learn the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
See the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.
Specifically, you will learn:
-The scope of IEC 60601-1 standards & if they apply to your product.
-What you need to know to classify your products to the IEC 60601-1 series.
-What is an isolation diagram and how does that help me with my design?
-Determine the applicable tests for your device.
-What are the marking and labeling requirements for the device?
-Know your critical components.
-What pre-tests to run and what’s not worth testing?
-Resources to help with this process and ways to reduce the paperwork off your backs.
Watch the presentation here: https://www.greenlight.guru/webinar/iec-60601-1
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
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.
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.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
Speed your time to market by following the step-by-step instructions.
You'll learn the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
See the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.
Specifically, you will learn:
-The scope of IEC 60601-1 standards & if they apply to your product.
-What you need to know to classify your products to the IEC 60601-1 series.
-What is an isolation diagram and how does that help me with my design?
-Determine the applicable tests for your device.
-What are the marking and labeling requirements for the device?
-Know your critical components.
-What pre-tests to run and what’s not worth testing?
-Resources to help with this process and ways to reduce the paperwork off your backs.
Watch the presentation here: https://www.greenlight.guru/webinar/iec-60601-1
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
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.
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.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
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.
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
[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
IEC 60101-1 is basic certificate for the general purpose as below items :
MEDICAL ELECTRICAL EQUIPMENT
MEDICAL ELECTRICAL SYSTEMS: Assembled by several medical electrical equipment
Components that is used in above equipment
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
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
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
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.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
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.
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
[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
IEC 60101-1 is basic certificate for the general purpose as below items :
MEDICAL ELECTRICAL EQUIPMENT
MEDICAL ELECTRICAL SYSTEMS: Assembled by several medical electrical equipment
Components that is used in above equipment
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
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
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
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.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Shahid, M., & Kamran, F. (2015). Causal Relationship between Macroeconomic Factors and Stock Prices in Pakistan. International Journal Of Management And Commerce Innovations, 3(2), 172-178. Retrieved from http://researchpublish.com/journal/IJMCI/Issue-2-October-2015-March-2016/0
Virtual teams - Learnings from Crisis Management Teams for Distributed Agile ...Rolf Häsänen
Learnings from improving Virtual Crisis Management team performance and applying this to distributed Agile Teams
Take aways
-Learn why we need to pay attention to Team Situational Awareness especially for distributed / virtual teams.
-Learn the Team Situational Awareness Model and how it can be used
In this short talk I’ll cover the term ‘inside attacker’. What does it mean and what are the stats? Are inside attacks getting worse or better? If worse, what can we do about that?
Presented at DevOpsDays Kansas City, Sept 21 2017.
Human error and secure systems - DevOpsDays Ohio 2015Dustin Collins
We see reports all the time with headlines like "90% of data breaches caused by human error". But what does that really mean? In this talk I will cover the traditional view of human error and how it hinders our ability to develop and maintain secure systems. Other industries have improved safety and security by shifting their view of human error. We can apply many of the the same concepts to software development and operations, minimizing risk and maximizing learning opportunity.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
Session 08_Risk Assessment Program for YSP_Risk Treatment and CommunicationMuizz Anibire
Program Objectives
In light of industrialization trends across the globe, new hazards are constantly introduced in many workplaces. This program aims to provide Young Safety Professionals (YSPs) from diverse backgrounds with the requisite skill to address the health and safety hazards in the modern workplace.
The International Society for Pharmaceutical Engineering (ISPE) would like to submit comments on the revision of Annex 1, on manufacturing of sterile medicinal products, of the Eudralex Volume 4.
Understanding Risk Management & Cyber security Principles in Medical DevicesKeerthi Gunasekaran
The reality is Risk Management is one of the more complex aspects of compliance and product efficacy, as risk comes in so many forms and perceptions, and on top of it risk assessments can be interpreted differently across a sector. Often decisions must be made with not enough data to accurately quantify risks. This course teaches the principles and org mindset needed to manage RM and setup cyber security. An Excerpt from ASQ MN presentation by the author Keerthi Gunasekaran
Hierarchical Digital Twin of a Naval Power SystemKerry Sado
A hierarchical digital twin of a Naval DC power system has been developed and experimentally verified. Similar to other state-of-the-art digital twins, this technology creates a digital replica of the physical system executed in real-time or faster, which can modify hardware controls. However, its advantage stems from distributing computational efforts by utilizing a hierarchical structure composed of lower-level digital twin blocks and a higher-level system digital twin. Each digital twin block is associated with a physical subsystem of the hardware and communicates with a singular system digital twin, which creates a system-level response. By extracting information from each level of the hierarchy, power system controls of the hardware were reconfigured autonomously. This hierarchical digital twin development offers several advantages over other digital twins, particularly in the field of naval power systems. The hierarchical structure allows for greater computational efficiency and scalability while the ability to autonomously reconfigure hardware controls offers increased flexibility and responsiveness. The hierarchical decomposition and models utilized were well aligned with the physical twin, as indicated by the maximum deviations between the developed digital twin hierarchy and the hardware.
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About
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
• Remote control: Parallel or serial interface.
• Compatible with MAFI CCR system.
• Compatible with IDM8000 CCR.
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
• Easy in configuration using DIP switches.
Technical Specifications
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
Key Features
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
• Remote control: Parallel or serial interface
• Compatible with MAFI CCR system
• Copatiable with IDM8000 CCR
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
Application
• Remote control: Parallel or serial interface.
• Compatible with MAFI CCR system.
• Compatible with IDM8000 CCR.
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
• Easy in configuration using DIP switches.
Saudi Arabia stands as a titan in the global energy landscape, renowned for its abundant oil and gas resources. It's the largest exporter of petroleum and holds some of the world's most significant reserves. Let's delve into the top 10 oil and gas projects shaping Saudi Arabia's energy future in 2024.
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1. Risk Management
in IEC 60601-1 3rd Edition
Presented by Alberto Paduanelli
Medical Devices Lead Auditor, MHS-UK, TÜV SÜD Product Service
2. –Time of presentation: 50-60 min.
–Questions & answers time at the end: 10 min.
–Entire webinar will be available for download from our
website www.tuvps.co.uk. You will also find it on
YouTube.
General Information
3. – Understanding the importance of Risk Management
– Understanding the RM requirements from the 60601-
1:2006 point of view
– Provide a clear picture of what is required
– Basic view on the creation and content of a RMF
Goals
4. What is risk management?
Risk Management in 60601-1 3rd edition
Methods for the visualization and identification of harms
and hazards
Creating a RMF – Minimal Documentation
Common errors when creating a RMF
Content: Modules
6. • BS EN ISO 14971:2009 definition:
• Risk Management:
systematic application of management policies, procedures
and practices to the tasks of analysing, evaluating,
controlling and monitoring risk
• Risk:
combination of the probability of occurrence of harm and the
severity of that harm
Definition
7. Risks and associated measures are called in:
43 sections in the MDD
14 sections in the AIMDD
34 sections in the IVD
4 sections in the ISO 13485
35 sections in the CMDR
3 sections in the J-GMP
153 sections in 60601-1 3rd Edition
Risk in the centre of attention
8. Results of risk management:
• serve the definition and dimension of goods control
• influence the supplier evaluation activities
• deliver important inputs for the design process
• serve as criteria for the evaluation of design output
• show the necessity for design modifications
• serve the definition of process controls and the assigned
acceptance criteria
Why Risk Management ?
9. • Standards often define only the most important, absolutely
necessary measures.
• Standards are rarely up to date on technology.
• Standards have "typical" implementations in mind. Exotic concepts
may not be covered.
• Standards (often implicitly) assume a certain environment and
method of use.
• Standards often do not cover optional components of a product.
• Potential manufacturing problems are not covered by most safety
standards.
• Potential manufacturing failures are not covered in the safety
standards for active devices.
a risk analysis is necessary in any case!
But there are standards !!
10. • Standards
• Existing risk analyses of similar products
• Interviews with the design engineers
• Interviews with users of similar products
• Experience of the sales people
• Brainstorming in RA team
• Analysis of FDA Medical Device Reports and Incident Reports
(MAUDE database)
• Examination of existing risk mitigation measures; they assume often
implicitly the presence of a hazard.
• Information from the field for similar products, e.g. service statistics,
complaints, incidents
• Annex C and E of ISO 14971
How to find the hazards:
Where to Start ?
11. Examples from ISO 14971:2009 annex E:
Electromagnetic energy: line voltage, leakage current, electric fields,
magnetic fields
Thermal energy: high temperature, low temperature
Mechanical energy: gravity, vibration, stored energy
Chemical: Exposure of airway, tissues, environment or property
Biocompatibility: Toxicity of chemical constituents
Use error: Attentional failure, memory failure, rule-based failure, knowledge-
based failure, routine violation
Annex E can help !
12. risk analysis risk evaluation
risk control
production and
post production
information
All included in the Risk Management File.
Risk Management Process
15. • Introduction of risk management as an alternative method to
meet individual requirements of the standard and covering
risks not subject to a standard
• There are 1422 single requirements in the standard. 153
have a direct link to RM (key-words such as RMF,
unacceptable risk, etc.).
One of the Major Changes
16. • in specifying minimum safety requirements, provision is made for
assessing the adequacy of the design PROCESS when this is the only
practical method of assessing the safety of certain technologies such as
programmable electronic systems.
• Application of this principle is one of the factors leading to introduction of
a general requirement to carry out a RISK MANAGEMENT PROCESS.
In parallel with the development of the third edition of IEC 60601-1, a
joint project with ISO/TC 210 resulted in the publication of a general
standard for RISK MANAGEMENT of medical devices. Compliance with
this edition of IEC 60601-1 requires that the MANUFACTURER have a
RISK MANAGEMENT PROCESS complying with ISO 14971 in place
(see 4.2).
Also:
• Alternative method to meet individual requirements of the standard and
covering risks not subjects to a standard.
Why this major change?
17. 3.107 RISK MANAGEMENT
systematic application of management policies,
PROCEDURES and practices to the tasks of analyzing,
evaluating and controlling RISK
4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT
or ME SYSTEMS
A RISK MANAGEMENT PROCESS complying with ISO
14971 shall be performed. (That’s the requirement!!)
Clause and Definition
18. • A RISK MANAGEMENT PROCESS complying with ISO 14971 shall be
performed.
• Compliance is checked by inspection of the RISK MANAGEMENT FILE.
The requirements of this clause and all requirements of this standard
referring to inspection of the RISK MANAGEMENT FILE are considered
to be satisfied if the MANUFACTURER has:
– established a RISK MANAGEMENT PROCESS;
– established acceptable levels of RISK; and
– demonstrated that the RESIDUAL RISK(S) is acceptable (in
accordance with the policy for determining acceptable RISK).
Important To Remember
19. NOTE:
Where requirements of this standard refer to
freedom from unacceptable RISK, acceptability
or unacceptability of this RISK is determined by
the MANUFACTURER in accordance with the
MANUFACTURER’S policy for determining
acceptable RISK.
Important To Remember
20. • The RMP shall be performed by a team of different experts (e.g.
physicians, hardware experts, software experts,…..).
• The RMP must be conducted at start of designing the product for
new products. Retrospective RMP is NOT the correct method.
• The RMP is an ongoing process over the whole life cycle (think
Environment / Recycle as end of life?)
• The initial risk is evaluated without any safety means used.
Remember the Rule of 10: Costs to correct failures increase by 10
between different stages of product realization: Idea // design //
planning production // production // end tests // On the market.
FACTS !
21. • The standard itself can already be regarded as a generic
risk analysis including counter measures. If the standard
specifies for certain clauses concrete limits, then care shall
be taken if RMP is used to tailoring (adjust) these standard
limits.
• The overall residual risk shall be evaluated and documented
in the RMF. The overall residual risk is the risk for all
combined single risks. It might be, that each single risk
evaluated alone is accepted, but based on the fact that to
much single risks are at the borderline to the intolerable area
the overall residual risk can not be accepted.
FACTS !
22. In applying ISO 14971:
– The term “fault conditions” referred to in ISO 14971 shall include,
but shall not be limited to, SINGLE FAULT CONDITIONS identified in
this standard.
– The policy for determining acceptable RISK and the acceptability of
the RESIDUAL RISK(S) shall be established by the MANUFACTURER
.
– Where this standard or any of its collateral or particular standards
specify verifiable requirements addressing particular RISKS, and
these requirements are complied with, the RESIDUAL RISKS
addressed by these requirements shall be presumed to be
acceptable unless there is OBJECTIVE EVIDENCE to the contrary.
Risk Management within the 60601-1:2006
23. Compliance is checked by inspection of the RISK
MANAGEMENT FILE. The requirements of this clause and all
requirements of this standard referring to inspection of the
RISK MANAGEMENT FILE are considered to be satisfied if
the MANUFACTURER has:
– established a RISK MANAGEMENT PROCESS;
– established acceptable levels of RISK;
– demonstrated that the RESIDUAL RISK(S) is acceptable
(in accordance with the policy for determining acceptable
RISK).
Compliance
24. • The IEC 60601-1:2006 requires RMP in the following 3
situations:
1. A complete new hazard is identified, which is not
addressed in the standard:
- In such a case RMP is a MUST.
- Examples: New techniques are developed (innovation).
When is Risk Management required?
25. 2. If a clause refer to RMP, then it is justified by the standard
to use RMP to tailoring (adjust) concerned standard
requirements to the DUT (device under test). This means in
clear words: The RMP shall be conducted OR the defined
technical standard requirements must be exactly fulfilled.
- Example: Clause 8.4.2.c (2Ed.: 16.e), here accessible
voltages, e.g. 24Vdc could maybe be justified by RMP for
home use (e.g. At a ceiling host – accessible current bus-
bar), where it is ensured that the PATIENT has no catheters
(intact skin) and can be regarded comparable to an
OPERATOR.
When is Risk Management required?
26. 3. The clause does NOT refer to RMP:
- Example: Clause 8.6.6: PE-contact in a detachable socket
shall made contact before and interrupted after the supply
connections are contacted or interrupted.
On the first view it appears as RMP would NOT be possible,
because RMP is not mentioned in this subclause 8.6.6.
However clause 4.5 (Equivalent safety) is always possible !!!
When is Risk Management required?
27. 4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
Where this standard specifies requirements addressing particular
RISKS, alternative means of addressing these RISKS are acceptable
provided that the MANUFACTURER can justify that the RESIDUAL
RISKS that result from applying the alternative means are equal to or
less than the RESIDUAL RISKS that result from applying the
requirements of this standard.
Compliance is checked by inspection of the RISK MANAGEMENT
FILE.
(It must be pointed out that verification of compliance is as well here
linked to RMP, but additional evidence about equivalent safety is
required).
Equivalent Safety Concept
28. 4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
If the RESIDUAL RISK is greater than the RESIDUAL RISK achieved
by applying the requirements of this standard, the ME EQUIPMENT or
ME SYSTEM cannot be regarded as complying with this standard,
even if the RESIDUAL RISK is fully justified by other considerations
such as the clinical benefit to the PATIENT.
In such a case standard compliance is only given if:
- The RMP is done adequately and additional
- Equivalent safety is reached.
That means: It is permitted to deviate from given standard limits (e.g.
certain creepage distance values), but it is forbidden to deviate the
RESIDUAL RISK level of the standard in the more risky direction.
Equivalent Safety Concept
29. Changes of the defined pass/fail criteria of certain standard
requirements can NOT be solely justified by RMP alone, but
need as well be supported by equivalent safety.
• Example: To show objective evidence that the RESIDUAL RISK of the
standard is not tailored if e.g. 7,5 mm creep is accepted instead of 8,0
mm, is maybe difficult, because of the 7,5 mm . However objective
evidence could be supported by:
- Performing additional specific tests
- Using alternative safety features for risk reduction.
- Other methods.
This indeed mean that a comparison of RISK levels must be
done additional to RMP. To compare the RISK levels is only
possible by evaluation of the RMF!
Equivalent Safety Concept
30. That means in clear words:
The manufacturer can NOT determine the RESIDUAL RISK level as
he like, rather the manufacturer is at least bound to the current
Values of society. In case of a defined pass/fail criteria in the 60601-1
and no link to RMP, the manufacturer is even bound to the RISK level
predefined in the standard itself (equivalent safety).
Current values of society = the state of the art !
The state of the art = how the majority of the world wide experts
(not a view article writers or a few test houses only!) would judge
the case!
The state of the art is how the majority of user handle it
(Example EMC of medical systems configured in hospitals).
Equivalent Safety Concept
31. • Checking projects for compliance with EN 60601-1:2006 (incl. applicable
collateral and particular standards) requires a 100% verification of all
applicable clauses of that standard. This includes all those clauses
which refer to RM.
• If the manufacturer deviates from any of the verifiable requirements of
the standard, he must demonstrate equivalent safety (see clause 4.5),
usually the outcome of the risk management process, to be verified by
the test house.
• For new hazards, e.g. associated with innovative technology, the
manufacturer has the duty to include them in his risk management
process and also has to work with the test house for proper verification.
Clause 4.5 is not applicable for such hazards.
Your RMF under scrutiny
32. • Tailoring (adjust) the requirements of the standard to the
specific device is possible as long the RMP is done
according the rules required from ISO 14971 and IEC
60601-1.
Initial Conclusion
33. “Product certification (testing) according the 3rd Edition means that
the product needs to be tested in a test laboratory and additional an
audit according ISO 14971 must be conducted at the manufacturer
facility.”
Answer:
The concerned standard clause is 4.2 “RISK MANAGEMENT
PROCESS”. Within the “compliance” section it is written:
“Compliance is checked by inspection of the RISK MANAGEMENT
FILE.”
It is NOT allowed to substitute the standards words:
- inspection audit and
- FILE PROCESS.
That means: According to the standard the outcome of a RM-PROCESS
(= this is solely the RM-FILE) will be evaluated only.
RESULT: NO on-site audit required!!!
Confusion on the market
34. • RMP alone can be used, where a clause in 60601-1 refer to RM or a
totally new hazard is handled.
• The RMP must be conducted according ISO 14971. Risk Evaluation must be
based on the current values of society. Which means that the manufacturer
is not free to lower the safety level by increasing the level of acceptable
Risk so much that the current values of society are violated. See 3.2, 3.3 of
ISO 14971.
• In case of using the ALARP concept: If a Risk is in the ALARP region, then
the Risk must be reduced to a level as low as reasonably practicable
(ALARP) and additional the Risk/Benefit ratio must be evaluated.
• In case of Equivalent Safety in addition of fulfilling the current values of
society (1) and fulfilling the Risk/Benefit ratio (2) the remaining Residual
Risk level must be equal or less (3) to the Residual Risk level of applying
the specific requirement 60601-1.
Final Conclusion
35. Evaluating the RMF is required for:
- the MDD (CE commission)
- CB-scheme (IECEE).
The 3rd Edition does NOT change the role of
Notified Bodies, because they are bounded to EU law
more than to a standard !
Also Don’t Forget...
36. Methods for the visualization and
identification of harms and hazards
MODULE 3
37. system
sub-system element 1.1
sub-system element 1.2
system element 1
system element 2
system element 3
System elements:
function negated function
description of the functions:
System elements can be replaced by requirements or features of the device!
Additonal information IEC 61025
why could this
function
fail? E.g. by
systematic
HAZOP
approach
System Analysis - HAZOP
38. loss of blood
air infusion
damage of
vascular system
wrong blood
temperature
hemolysis
Harm Analysis
39. Failure blood
heating
Temperature sensor
defect
Short circuit
Cold soldering
point
Heating does not
work
Heating wire
broken
No energy
ADC delivers
wrong values
High noise
Wrong reference
voltage
Additional information in IEC 61025
Fault Tree Analysis
44. Question: What can be done to disable the system or harm the patient and how?
disconnect the
bubble detector
increase the
pump speed to
maximum
implement
sharp edges to
cause
hemolysis
Sabotage
45. FMEA: Failure mode and effects analysis
a method to
identify hazards
a method used for structuring
and evaluation risks
(similar to ISO 14971)
here
FMEA
47. FMEA in Production
Process step /
component
# Failure Harm Root
cause
A S E RPZ Risk control A S E RPN
packaging Insuffici
ent
steam
penetrati
on
Infection
by insterile
product
Wrong
packagin
g
material
6 1
0
8 480 Packaging
validation
1 1
0
8 80
Temperature
control
Tempera
ture
sensor
defectiv
e
Blood
heating
No
contact
5 1
0
1
0
500 Final testing
+ 100% Visual
inspection
5 1
0
1 50
A: Occurrence; S: Severity; E: Detectability;
RPN: Risk Priority Number
FMEA Example
48. top
down
bottom
up
hazard analysis (PHA)
fault-tree analysis (FTA)
Ishikawa
impulsive words
system analysis
(HAZOP)
system analysis (HAZOP)
black box
interface analysis
FMEA (as defined)
intended use,
function,
patient
realization
Differentiation
49. With what? With whom?
Input
With what? How?
OutputprocessRequirements Requirements
• Instructions
• Procedures
• Methods
• Training
• Knowledge
• Abilities
• performance
indicators
• Equipment
• Installation
Turtle – For Processes
50. Material Resources
With what (equipment,
material)
Process risks Human ressources
Who (training, knowledge)
- reflow soldering oven
- soldering paste
- function of the oven
- calibration
- paste specs
- no or insufficient instruction - craftsman electrical
engineering
- special briefing for the oven
Inputs Outputs
- PCB with paste and
components
- soldering programme
- PCB without paste
- missing components
- wrong soldering programme
- soldered PCB
- protocol of the oven
Performance indicators know how
How (Instructions,
procedures, methods)
- wrong soldering points
- Old work instruction
- component specification
wrong
- component specification not
available
- Instruction „Soldering with our
reflow oven“
- component specs
Turtle (for processes)
52. Intended use
Describe your device such that it is obvious who will use your device
what for and how.
Risk management plan
When, what, how something should be done by whom?
Scope
Describe for which part of the product life cycle the risk management file
is valid.
Definitions
What is…?
Qualification
Who was involved in risk management (development, doctor etc.)?
Minimal File
53. Severity and probability
Provide categories for severity and probabilities (including examples).
Acceptance matrix
Define the acceptance matrix (severity vs. probability). Include the
acceptable risk in your considerations.
Table
List the risks in a table with the following columns: harm, cause, severity
before measures, probability before measures, risk acceptance before
measures, risk mitigation measures including links to specifications and
verifications, severity after measures, probability after measures and risk
acceptance after measures.
Minimal File
54. Explanation for exceptional decisions
Exceptional decision have to be explained!
Acceptance matrix before and after mitigations
Fill out the matrix with the number of risks in each field before and after
mitigations.
Assessment of the overall remaining risk
Assess the overall remaining risk using the acceptance matrix after
mitigations. It might be worth to calculate the number of injuries/death
according to your matrix.
Production and post production information
How is the interface to the production ruled and how is the information
from the field (production, service, installation, user etc.) fed back.
Risk management report / approval
Minimal File
56. • Assess only the risks associated to the BIG issues
• Do a RMF retrospectively
• Not looking at residual risks
• No conclusion
• Associate ALARP to the meaning of “Acceptable” or “no actions involved”
• Thinking that Probability of Occurrence and Severity must always be multiplied
• Not involving experienced/specialists personnel in regards to the
process/product
• Not keeping the RMF a “live” document
• Using the RMF as an “escape route” to product re-design, improvements, CAPA,
etc...
• Not looking at the worst case scenario
• Make the RMF look good so that the auditor is happy !
Common Errors
57. Alberto Paduanelli
Medical Devices Lead Auditor, MHS-UK
TÜV SÜD Product Service
Tel: +44(0)1489 558219
apaduanelli@tuvps.co.uk
www.tuvps.co.uk