Biological Risk Evaluation and Management for Medical Devices

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Biological Risk Evaluation and Management for Medical Devices

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 FDAnews has 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

BONUS: The report also includes several 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
  • A copy of the FDA guidance, Use of International Standard ISO 10993-1.

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.

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Who Will Benefit

  • Design Project Leaders
  • Risk Management Professionals
  • Data Analysts
  • Laboratory Managers
  • Regulatory Affairs Managers

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