Design Control & Risk Management Reference Book


The Most Exhaustive Resource Available for Interpreting the Design Control Process (21 CFR 820.30 & ISO 13485) and Risk Management Process (ISO 14971) 

  • Interpretation and practical implementation of the Medical Device Design Control Process (FDA 21 CFR 820.30 & ISO 13485) & Risk Management (ISO 14971 (2007 & 2012)) Process
  • The most exhaustive resource ever written about design controls  for medical devices (FDA 21 CFR 820.30) with a collection of all applicable regulations and real-world examples.
  • This book walks step by step through the design control process, regulation and design control guidance
  • Explanation of ISO 14971 and example risk assessments and analysis are included.
  • Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820.30 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques.
  • This handbook also covers the design control process including basic, intermediate and advanced design control topics and is an ideal resource for implementing a new design control process or upgrading an existing design control process into a medical device quality system.
  • This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections as well as improve their understanding of the design control process.
  • The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble to assist medical device developers interpreting FDA's design control process.
  • Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise.
  • As an added bonus, web access to downloadable and editable design control documents are accessible on this website with the book purchase.
  • In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble.
  • 30-50 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.



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