Risk management design professionals (21 Ergebnisse)

Paperback. Zustand: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less.

Paperback. Zustand: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less.

Hardback. Zustand: Very Good.

Zustand: Good. Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions.…

Zustand: New.

Zustand: As New. Unread book in perfect condition.

Zustand: New.

paperback. Zustand: New. In shrink wrap. Looks like an interesting title.

Zustand: Fair. This is an ex-library book and may have the usual library/used-book markings inside.This book has hardback covers. Book contains pencil markings. In fair condition, suitable as a study copy. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,900grams, ISBN:9780471156079.…

Zustand: As New. Unread book in perfect condition.

Paperback. Zustand: Very Good. This handbook is ranked as a best seller and provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 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 basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process into medical device quality systems. 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. 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. 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 included with this 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.…

Paperback. Zustand: Fair. This handbook is ranked as a best seller and provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 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 basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process into medical device quality systems. 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. 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. 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 included with this 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.…

Zustand: New.

Zustand: New.

Zustand: New.

Zustand: As New. Unread book in perfect condition.

Zustand: As New. Unread book in perfect condition.

Zustand: New.

Zustand: New. In English.

Zustand: New.

Hardcover. Zustand: Brand New. 465 pages. 9.50x6.25x1.00 inches. In Stock.