Edwin L Bills
Instructor Edwin L Bills
Product Id 600058
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

Integrating Risk Management Into the Quality System


ISO 14971 medical device risk management standard was updated in 2007 after its initial release in 2000.

Yet today companies are still struggling with implementing this standard. At the same time, many other standards are referring to ISO 14971. Risk Management is a requirement of quality system standards such as ISO 13485 and considering risk is also a requirement of the US FDA Quality System Regulation, 21 CFR 820. A major change for electro-medical devices in the 3rd edition of IEC 60601-1 which will be required in 2012, is the use of risk management throughout the standard and its collateral and particular components. Companies need to complete integration of ISO 14971 in their design, production and post-production activities before they encounter audits and inspections that find fault with their risk processes, causing delay or worse recall of products.

Areas Covered in the seminar:

  • Risk Management processes as defined in guidance, standards and regulations
  • Design Risk Management as part of a quality system
  • Post-design Risk Management within a quality system
  • Connecting CAPA and Risk Management in the quality system
  • Creating a compliant Risk Management process
  • Avoiding product problems using Risk Management

Who Will Benefit:

  • Product Risk Management
  • Design Team members and Management
  • Human Factors Engineers
  • Regulatory Affairs Management
  • Project Managers
  • Process Engineers
  • Quality Engineers and 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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