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All biomaterials and medical devices are subject to a long list of regulatory practices and policies that must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on procedures and policies including topics such as commercialization, clinical development, general good practice manufacturing, and post market surveillance.
- Addresses global regulations and regulatory issues surrounding biomaterials and medical devices
- Especially useful for smaller companies who may not employ a full time compliance professional
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Anmol
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