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 must demonstrate that product
design, process, and test methods/requirements/specifications
determined during development can be met in the environment of
intended use. This book provides practical guidance on how to
develop and validate product designs, manufacturing processes, and
test methods that comply with the requirements of QSR.
General
| Imprint: |
Crc Press
|
| Country of origin: |
United States |
| Release date: |
September 1997 |
| First published: |
2007 |
| Authors: |
Carol V. Desain
• Charmaine V. Sutton
|
| Dimensions: |
229 x 152 x 19mm (L x W x T) |
| Format: |
Hardcover
|
| Pages: |
336 |
| Edition: |
2nd edition |
| ISBN-13: |
978-1-57491-063-6 |
| Categories: |
Books >
Medicine >
General issues >
General
|
| LSN: |
1-57491-063-9 |
| Barcode: |
9781574910636 |
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