Medical Device Guidelines and Regulations Handbook
2022 ed.
Book Details
Format
Paperback / Softback
ISBN-10
3030918572
ISBN-13
9783030918576
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, 2023
Print length
385 Pages
Product Classification:
Biomedical engineeringBiomedical engineering / Medical engineering
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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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