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Ensuring Regulatory Compliance

Ogrodnik, Peter J.



Chapter 6 provides an overview of the world of medical device regulations required for taking a design concept through to a marketable product. A brief glimpse of historical guidelines demonstrates how advancing technology has shaped new guidance such that the safety of users and those in the surrounding environment is maintained. This is a fast-changing area which, in the UK, will be affected by Brexit, though quite to what extent remains uncertain.


Ogrodnik, P. J. (2021). Ensuring Regulatory Compliance. In Medical Textiles (147-180). CRC Press.

Online Publication Date Dec 22, 2021
Publication Date Nov 17, 2021
Deposit Date Jun 14, 2023
Publisher CRC Press
Pages 147-180
Book Title Medical Textiles
Chapter Number 6
ISBN 9781003170570
Publisher URL