Medical Device Guidelines and Regulations Handbook
Author | : Prakash Srinivasan Timiri Shanmugam |
Publisher | : Springer Nature |
Total Pages | : 382 |
Release | : 2022-04-22 |
Genre | : Technology & Engineering |
ISBN | : 3030918556 |
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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.