Risk Management in IEC 60601-1 Third Edition

Edwin L Bills
Instructor Edwin L Bills
Product Id 600100
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Risk Management in IEC 60601-1 Third Edition

Overview:
IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.

This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be withdrawn. Devices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the requirements of the new standard.

Areas Covered in the Session:

  • ISO 14971 compliance is a requirement of IEC 60601-1
  • The new standard uses risk management throughout
  • The new standard is less prescriptive in many areas
  • The new standard requires that all applicable collateral and particular standards must be used for compliance
  • Current activities leading to full implementation of the standard
  • Available documents to guide implementation of the Third Edition

Who Will Benefit:

  • Design Engineers
  • Quality Engineers and Managers
  • Compliance Engineers
  • Engineering Managers
  • Project Managers
  • Verification and Validation Engineers and Mangers
Speaker Profile
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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