Use of Risk Management to Meet Requirements of IEC 60601-1

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Use of Risk Management to Meet Requirements of IEC 60601-1

Use of Risk Management to Meet Requirements of IEC 60601-1

Instructor : Edwin L Bills

Product Id : 600232

Overview: This presentation will examine the requirements of IEC 60601-1 for use of ISO 14971 risk management and interpret those requirements.

In addition, there will be practical examples of application and documentation of risk management activities in a manner that meets IEC 60601-1 and ISO 14971 requirements.

Why Should You Attend:The new edition of IEC 60601-1 requires the use of the medical device risk management standard ISO 14971 to meet IEC 60601-1 requirements. This philosophy is new to the medical device industry and companies are struggling with interpreting this new requirement.

Areas Covered in the Session:

Documentation requirements of IEC 60601-1
Documentation requirements of ISO 14971
Use of Risk Management with Collateral and Particular IEC 60601 standards
Documenting hazards and hazardous situations from IEC 60601-1 family
Examples of documentation practices to meet requirements of both standards

Who Will Benefit:

Risk Managers
Quality Engineers
Compliance Engineers
Design Engineers
Quality Managers
Regulatory Affairs
Other Risk Management Team members
Internal and External Auditors

During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.

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