Medical Device Guidelines and Regulations Handbook (Original PDF from Publisher)

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