FDA, Good Manufacturing Practices GMP, quality system, QSR, ISO 13485, regulatory consultants, manufacturing development device, drug, diagnostic, combination medical products, 510k, PMA, IDE
Other Books
by Carol DeSain & Charmaine Sutton


Validation for Device and Diagnostic Manufacturers second edition
by Carol DeSain and Charmaine Vercimak Sutton
book, protocols, reports, master plan, method, process, product, development, qualification, installation, operational, good manufacturing practices, examples, documents
Soft cover book - $192.00: To Order
Electronic copy - $179.96 (PDF): To Order
Learn more about book: Book Description

Meeting GMP and ISO 9001 Expectations for Product Development
by Charmaine Vercimak Sutton and Carol DeSain
book, design control, input verification, validation, review, development, clinical trial, plans, history file, DHF, ISO 13485, PMA, 510k, IDE, example documents
Soft cover book - $145.00: To Order
Learn more about book: Book Description

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