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Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
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Design Controls for the Medical Device Industry
This second edition of a bestseller provides a comprehensive review of design control requirements, as well as techniques to ensure your design control program follows current industry practice. The text assists you in developing a program that not only satisfies US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets third-party auditor/investigator expectations. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in practical updates to all chapters and appendices of the book.

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  • Publisher: CRC Press
  • Publication Place: UK
  • Publication Year: 2017-04-21
  • Language: English
  • Number of Pages: 208
  • Edition: 2
  • Seller: BestBookBuddies  
  • Category: RAPS
  • Stock: 9999
  • Model: Stock
  • Weight: 0.38kg
  • SKU: Stock
  • ISBN: 9781138073715
  • Sold By: taylorandfrancis
  • Contact Seller
  • ₹4,846.30
    ₹6,057.88
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