This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and ISO 9001:2015 and 13485:2016 standards, but also meets today's Notified Body auditors' and FDA investigators' expectations. Areas addressed are ...
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This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and ISO 9001:2015 and 13485:2016 standards, but also meets today's Notified Body auditors' and FDA investigators' expectations. Areas addressed are design planning, input, output, review, verification, validation, change, transfer and history. The FDA Quality System Inspection Technique (QSIT) is also covered in-depth.
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Add this copy of Design Controls for the Medical Device Industry, Third to cart. $100.42, good condition, Sold by HPB-Red rated 5.0 out of 5 stars, ships from Dallas, TX, UNITED STATES, published 2019 by CRC Press.
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Add this copy of Design Controls for the Medical Device Industry, Third to cart. $159.42, new condition, Sold by Media Smart rated 4.0 out of 5 stars, ships from Hawthorne, CA, UNITED STATES, published 2019 by Taylor & Francis Group.
