Design controls for the medical device industry
"Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also su...
Saved in:
| Main Author: | |
|---|---|
| Format: | eBook |
| Language: | English |
| Published: |
Boca Raton :
Taylor & Francis,
[2013]
|
| Edition: | Second edition. |
| Subjects: | |
| ISBN: | 9781466503557 1466503556 9781628707120 1628707127 9781466503540 1466503548 |
| Physical Description: | 1 online resource |
Cover
Table of contents
| Summary: | "Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also subject to design control requirements. This second edition of a bestselling book expands and updates all chapters with detail on current design control requirements, more examples, and further explanation and clarification of the requirements. The book also addresses device risk and classification, and covers risk management in its own chapter. Appendices have also been revised"--Provided by publisher |
|---|---|
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 9781466503557 1466503556 9781628707120 1628707127 9781466503540 1466503548 |
| Access: | Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty |
Save to List
Cite this
Export Record
Email this