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Edwin L Bills
Instructor Edwin L Bills
Product Id 600192
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

Understanding the new IEC 60601-1 Third Edition

Overview:

Now that the FDA has become the last regulator to indicate they will recognize IEC 60601-1 Third Edition, it is important that device manufacturers understand this standard as they need to begin implementation in current and future design projects of elec

This complex standard will require changes in the design process and also require new tests of devices to be performed before market clearance and release.

Areas Covered in the Session:

  • The structure of IEC 60601-1 Third Edition
  • Integration of Risk Management in the standard
  • Requirements for use of Collateral and Particular Standards
  • New test requirements and expected test backlog
  • Pending Amendment of the Third Edition
  • Changes to Design Processes

Who Will Benefit:

  • Design Engineers and Managers
  • Design Verification Engineers
  • Quality Engineers and Managers
  • Compliance Engineering
  • Regulatory Affairs Managers

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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