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Medical Device Guidelines and Regulations Handbook
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Medical Device Guidelines and Regulations Handbook

2022 ed.

Book Details

Format Hardback or Cased Book
ISBN-10 3030918548
ISBN-13 9783030918545
Edition 2022 ed.
Publisher Springer Nature Switzerland AG
Imprint Springer Nature Switzerland AG
Country of Manufacture GB
Country of Publication GB
Publication Date Apr 23rd, 2022
Print length 385 Pages
Product Classification: Biomedical engineering
Ksh 19,800.00
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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.

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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