Design Controls for the Medical Device Industry, Third Edition
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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.
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 13485:2016 standards, but also meets today''s Notified Body Auditors'' and FDA Investigators'' expectations.
The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study.
This third edition:
- Examines new coverage of ISO 13485-2016 design control requirements
- Explores proven techniques and methods for compliance
- Contributes fresh templates for practical implementation
- Provides updated chapters with additional details for greater understanding and compliance
- Offers an easy to understand breakdown of design control requirements
- Reference to MDSAP design control requirements
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