Day 2 – Session

A session at 2-day In-person Seminar on “Implementing Risk Management Principles & Activities within Quality Management System” at Singapore

Friday 28th February, 2014

9:00am to 6:00pm (SMT)

Lecture 3: IEC 60601-1 3rd edition (incl. A1)

References to Risk Management
Section 4 Risk Related Issues
Compliance for Non-Software Related Issues
The IEC TRF (technical report form)
Special PEMS Issues
PEMS and IEC62304

Lecture 4: Usability Risk Management (IEC62304:2006 / FDA usability Guidance)

Use errors as hazard source
User intervention as hazard mitigation
Usability engineering lifecycle
Application specification
Usability Specification
Frequently used functions / primary operating functions
Usability verification / validation
Upcoming changes IEC62366:2014

Lecture 5: Software Risk Management (IEC62304 / FDA software reviewers' guidance):

Critical Software Issues
Software Hazard Mitigation Strategies
Software Item, Unit and System Definition
Software Failures as Hazard Sources
Software Requirements and Design Specification
Software Tools and Development Environment
Software Unit and Integration Testing
Real-Time System Challenges
Software Verification and Validation
Mitigation Traceability and Effectiveness
Software Maintenance and Configuration Control
Software Risk Management Process integration into ISO14971
Legacy Software issues
FD documentation requirements
Upcoming changes in IEC62304:2014

About the speaker

This person is speaking at this event.
Markus Weber

Principal Consultant, System Safety Inc.

Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

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Time 9:00am6:00pm SMT

Date Fri 28th February 2014

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