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Medical Device Guidelines and Regulations Handbook

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

Information

  • Publisher
  • ISBN
  • ePub ISBN
  • Springer
  • 9783030918552
  • 9783030918545
  • Published at
  • Pressing
  • 2022
  • 1

About this book

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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