Medical Device Guidelines and Regulations Handbook

By Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath 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. Product Details Publisher ‏ : ‎ Springer; 1st ed. 2022 edition (April 23, 2022) Language ‏ : ‎ English Hardcover ‏ : ‎ 391 pages ISBN-10 ‏ : ‎ 3030918548 ISBN-13 ‏ : ‎ 978-3030918545 ISBN-13 ‏ : ‎ 9783030918545 eText ISBN: 9783030918552