Medical Device Guidelines and Regulations Handbook
Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath, 3030918548, 978-3030918545, 9783030918545, B09YNPDRPM, 978-3-030-91854-5, 978-3-030-91855-2
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.