Free Design Control & Risk Management Reference Book

In addition to the training materials, a free design controls, risk management & process validation reference book is included with every training course (Design Controls, Risk Management & Process Validation for Medical Device Professionals; $130 value as sold on Amazon.com) Author: Vern Geckler

 

  • FDA Regulation Cross Referencing
  • Project Management Integration
  • Practical Best Practices & Templates
  • Case Studies & Examples
  • Regulation, Guidance and Preamble Included
  • 440+  Pages (8.5 X 11)
  • Design Controls (21 CFR 820.30)
  • Risk Management (ISO 14971)
  • Process Validation (21 CFR 820.75)
  • $130 value

 

Purpose of the Book
Over the last two decades since the design control regulation was introduced, the valuable  and detailed knowledge for implementing design control systems, outside the walls of the FDA, has been retained in the minds of a group of medical device industry consultants which varies greatly depending on the consultant’s experience.

The purpose of this book is to capture the last two decades of design control expertise from industry experts and through detail interpretation of design control regulation and guidance. This book is a download of the author’s experience and industry expert’s knowledge of design control best practices and practical implementation guidance which is cross-referenced with the regulation, design control guidance, and quality system preamble.

This book is also intended to provide medical device professionals with one point of reference when trying to understand medical device regulation. There are numerous medical device new product development regulations, standards and guidance documents that are scattered across the FDA website and internet. It can be quite a daunting task to understand them all. This book attempts to bring all of those resources together either by reference or by including the actual document in this book when possible.

This book was also written to provide additional guidance, interpretation, examples and case studies to help medical device professionals solidify their understanding of medical device regulation.