Additional information
| Full Title | Medical Device Guidelines and Regulations Handbook |
|---|---|
| Author(s) | |
| Edition | |
| ISBN | 9783030918552, 9783030918545 |
| Publisher | Springer |
| Format | PDF and EPUB |
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| Full Title | Medical Device Guidelines and Regulations Handbook |
|---|---|
| Author(s) | |
| Edition | |
| ISBN | 9783030918552, 9783030918545 |
| Publisher | Springer |
| Format | PDF and EPUB |
This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.