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Medical Device Guidelines and Regulations Handbook
Timiri Shanmugam, Prakash Srinivasan ; Thangaraju, Pugazhenthan ; Palani, Nandakumar (Author)
·
Springer
· Paperback
Medical Device Guidelines and Regulations Handbook - Timiri Shanmugam, Prakash Srinivasan ; Thangaraju, Pugazhenthan ; Palani, Nandakumar
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Synopsis "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.
