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Biological Risk Evaluation and Management for Medical Devices
**An FDAnews Management Report**
http://www.fdanews.com/products/54417-biological-risk-evaluation

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. Readers 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 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 devicemakers 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
  • Data Analysts
  • Laboratory Managers
  • Regulatory Affairs Managers

FDAnews Management Report Details:
Biological Risk Evaluation and Management for Medical Devices
**An FDAnews Management Report**
Price: $397
http://www.fdanews.com/products/54417-biological-risk-evaluation

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54417-biological-risk-evaluation
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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