@article{1446218, note = {Includes index.}, author = {Shanmugam, Prakash Srinivasan Timiri, and Thangaraju, Pugazhenthan, and Palani, Nandakumar, and Sampath, Thamizharasan,}, url = {http://library.usi.edu/record/1446218}, title = {Medical device guidelines and regulations handbook /}, abstract = {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.}, doi = {https://doi.org/10.1007/978-3-030-91855-2}, recid = {1446218}, pages = {1 online resource (vi, 385 pages) :}, }