Regulatory Focus™ > News Articles > Inadequate Medical Device Validation a Common Problem; RAPS Publishes 'How-to' Resource

Inadequate Medical Device Validation a Common Problem RAPS Publishes 'How-to' Resource

Posted 16 April 2015 | By Zachary Brousseau 

Inadequate Medical Device Validation a Common Problem RAPS Publishes 'How-to' Resource

Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device manufacturers have to interpret broad and varying definitions within FDA’s regulations and a related guidance document on the topic. Until now, there has been no comprehensive resource to help regulatory and quality professionals, and other stakeholders navigate device validation.

A New Device Validation Reference

Today, RAPS published its new Medical Device Validation Handbook, edited by Max Sherman, providing a unique compilation of expert thought and analysis of the validation and verification processes for medical devices. The book examines multiple aspects of validation, including process, design, software, equipment and cleaning validation.
“People need a greater understanding of what validation consists of, as well as the process of validation itself,” says Sherman. Validation can be confusing, he says. “It has a language all its own.” Sherman, who has 40 years of regulatory experience, recently spoke to Regulatory Focus about the book and the need it fills.

The Validation Handbook includes chapters on:

  • design and process validation
  • risk-based verification and validation
  • sterilization validation principles
  • medical packaging validation
  • six sigma concepts in packaging validation
  • cleaning validation
  • software validation
  • FDA Unique Device Identification verification and validation
  • equipment validation
  • sample sizes; and verification and validation in medical device computational modeling and simulation

Several chapters cover topics that cannot be found in any other book. Chapter One: Introduction and History is available online as a free sample chapter.

How to Purchase

The Medical Device Validation Handbook is available from the RAPS Store in print and e-book formats, or both versions can be purchased together in a discounted bundle.


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