Translating government gobbledygook into English is no small task. And the FDA isn’t the only regulator to worry about. Misinterpret a few words of the EU regs and see how much trouble you’ll land in.
Lucky for you we have done the work for you.
Biological Risk Evaluation and Management for Medical Devices shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards. You will learn the following:
*How to interpret and follow ISO standards on risk management (14971:2007) and biological evaluation (10993-1:2009)
*How to structure risk management efforts and set acceptability criteria
*How to qualify personnel to evaluate risk
*Definitions of acceptable risk, unacceptable risk and residual risk
*Testing requirements for identifying biological hazards
*How to use the FDA’s guidance on following ISO 10993 along with the ISO Technical Report 15499:2016
*How the EU’s versions of ISO 10993 and 15499 differ from the originals
*The biocompatibility expectations of the EU’s new Medical Device Regulation
The webinar also includes several reference materials related to risk management and biocompatibility evaluation aids including:
*A table comparing the requirements of ISO standard 14971, ISO standard 10993 and ISO technical report 15499;
*A table comparing the risk management requirements contained in the former EU Medical Device Directives with those in the new MDR; and
Biological Risk Evaluation and Management for Medical Devices will give you an understanding of how to evaluate biological hazards associated with a device within a risk management framework.
Who Will Benefit:
*Design Project Leaders
*Risk Management Professionals
*Regulatory Affairs Managers
Duration: 60 Minutes
Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version
Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.