Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971

Medical Device companies are creating Risk Analysis as required by ISO 14971, yet the analyses created do not meet the requirements of the standard. Many companies are using Failure Modes and Effects Analysis as their complete Risk Analysis, and are not in compliance with the standard. The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard.

Areas Covered in the seminar:

• Requirements for Risk Analysis under ISO 14971
• Creation of documentation meeting the requirements
• Documents that meet the requirements and provide value to the company

Who will benefit:

This webinar will update personnel at medical device companies on the new standard and point them to the additional information available in the newly revised document. The information will assist in meeting various national and global regulatory requirements for medical devices.

• Design personnel using risk management during development of new medical devices.
• Quality Manager responsible for integrating risk management into quality systems.
• Regulatory and compliance personnel who develop premarket filings and technical files for medical devices.
• Personnel responsible for verification and validation activities.
• Quality system auditors.

Instructor Profile:

Edwin L. Bills , has over 20 years experience in the field of Quality and Regulatory Affairs. 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 the committee. In this position he represented the United States on the ISO/IEC Joint Working Group on risk management for medical devices, the group responsible for authoring ISO 14971, the medical device risk management standard. He also served as the liaison between ISO TC 194 Sterilization Standards and IEC SC 62 Medical Electrical standards. Mr. Bills has presented courses for the American Association of Medical Instrumentation (AAMI) and the Advanced Medical Technology Association (AdvaMed), and as guest lecturer at the University of Southern California graduate program in Regulatory Affairs and the University of Washington certificate program in Regulatory Affairs.

Currently he is the Principal Consultant at Bilanx Consulting LLC in the area of Medical Device Quality, Regulatory, Product Liability and Risk Management. Working as a consultant, Mr. Bills has assisted major medical device manufacturers improve their risk management processes to comply with regulatory requirements and international standards. He has also assisted with the development and improvement of design, development, manufacturing and service processes and preparation of pre-market submissions for manufacturers in the medical device industry. Mr. Bills has also provided expert services to legal counsel in the area of risk management and FDA compliance.

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