Record Identifier: | 275763 |
Title: | Medical device guidelines and regulations handbook / |
Authorstatement: | Shanmugam, Prakash Srinivasan Timiri, ; |
Date of Publish: | 2022 |
Publisher: | Springer |
ISBN: | 9783030918552 ; (electronic bk.) ; |
ISBN: | 3030918556 ; (electronic bk.) ; |
ISBN: | 9783030918545 ; (print) ; |
ISBN: | 3030918548 ; |
Subject: | Medical instruments and apparatus. ; |
LC classes: | R856 ; |
Dewey Classes: | 610.28/4 ; 23/eng/20220427 ; |
This comprehensive resource features in-depth discussions of important guidelines and regulations you will need 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 ;