How Design Verification, Design Validation, Process Validation, and Risk Management Work Together in Producing Safe Medical Devices

Instructor: Edwin L Bills
Product ID: 701496
Training Level: Advanced
  • Duration: 80 Min

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Read Frequently Asked Questions

This webinar will teach how Design Verification and Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.

Why Should You Attend:

FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, Process Validation and recently has issues Warning Letters including failures of manufacturers in Risk Management. After the design of a medical device is complete, there are still many steps that must be taken prior to releasing a medical device to the market. Each of these steps is important to assuring a safe device is released to market and is required to meet regulatory requirements, as well as the requirements embedded in standards. The requirements in these steps were developed as a response to issues with devices that led to adverse events and recalls.

This webinar will show how Design Verification, Design Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices. Also discussed are risk management documentation tools used to meet the requirements of the ISO 14971 standard during these final phases of product development. Not only will meeting regulatory requirements be a subject of the presentation, but also doing so efficiently.

Areas Covered in the seminar:

  • What exactly are FDA and ISO 13485 requirements for Design Verification, Design Validation, and Process Validation?
  • How does Risk Management integrate into these later phases of product development?
  • What Design Output requirement is key to these late design phases and also to meeting requirements of Purchasing Controls?
  • What Design Verification and Design Validation requirements are established in the Risk Management standard?
  • How does Process Validation impact the Design Validation process?
  • How can I efficiently meet documentation requirements of the Risk Management standard during the late design phases?
  • How are suppliers involved in the late design phases?

Who will benefit:

This webinar is focused on medical device manufacturers and the need to produce safe devices meeting the regulatory requirements of the US FDA, the EU MDD, and other regulatory schemes throughout the world.
  • QA managers and personnel
  • Verification and Validation specialists
  • Quality system auditors
  • Process validation specialists
  • Product design managers
  • Regulatory Affairs
  • Risk Managers

Instructor Profile:
Edwin L. Bills, 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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