Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies
| ISBN: | 9781439810460 |
| Publication date: | 30th September 1997 |
| Author: | Desain, Carol V.|Sutton, Charmaine V. |
| Publisher: | CRC Press |
| Format: | Ebook (PDF) |