Medical Device Guidelines and Regulations Handbook

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.

• Format: Hardcover
• Language: English
• ISBN: 3030918548
• ISBN13: 9783030918545
• Release Date: April 2022
• Publisher: Springer
• Length: 385 Pages
• Weight: 1.79 lbs.
• Dimensions: 0.9" x 6.4" x 9.5"