Medical Device Guidelines and Regulations Handbook

Timiri Shanmugam, Prakash Srinivasan; Thangaraju, Pugazhenthan; Palani, Nandakumar; Sampath, Thamizharasan

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.

Details

Published by: Springer

Publication Date: 2023-04-23

Format: Paperback

ISBN-13: 9783030918576

DOI: 10.1007/978-3-030-91855-2

Dimensions: 235.0cm x155.0cm

Pages: 385.0