FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing.
It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in the US, the EU, and other parts of the world. Taught using an interactive workshop format, attendees will practice all the risk management activities required by ISO 14971. Exercises are aimed at demonstrating efficient and effective use of risk management, including best practices in applying the ISO standard. Emphasis is placed on practical solutions to practical problems. Seminar instructor Harvey Rudolph, Ph.D., one of the authors of ISO 14971 and a 25 year veteran of FDA, will also provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.
Seminar Instructor Dr. Harvey Rudolph is an ex-FDA official having spent 25 years with FDA and one of the authors of ISO 14971. He will provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.
- To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle
- To demonstrate the requirements of ISO 14971, how they reflect FDA concerns
- To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements
- To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers
- To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012
- To provide attendees with the Dos and Don’ts for an effective and efficient risk management system
Who will benefit:
- Project managers
- Quality managers and staff
- R & D managers and staff
- Regulatory and compliance managers and staff
- Anyone with risk management responsibilities
The 3rd edition of IEC 60601 adds further fuel to the fire with the requirement that electro-medical device manufacturers have a risk management process in place conforming to ISO 14971. Manufacturers that market devices in the European Union have found additional requirements for their risk management activities as detailed in EN/ISO 14971:2012.
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