Ensuring Regulatory Compliance

Ogrodnik, Peter J.

Abstract

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.

Citation

Ogrodnik, P. J. (2021). Ensuring Regulatory Compliance. In Medical Textiles (147-180). CRC Press. https://doi.org/10.1201/9781003170570-6

• 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
• DOI: https://doi.org/10.1201/9781003170570-6
• Publisher URL: https://www.taylorfrancis.com/chapters/edit/10.1201/9781003170570-6/ensuring-regulatory-compliance-peter-ogrodnik