Medical Device Guidelines and Regulations Handbook

Medical Device Guidelines and Regulations Handbook

Author
Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath
Publisher
Springer
Language
English
Year
2022
Page
381
ISBN
3030918548,9783030918545
File Type
pdf
File Size
3.7 MiB

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.

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