London-based medical device regulatory consultancy Quality First International has written a basic guide to the use of standards to demonstrate fulfilment of product specification, conformity with European regulations or specified requirements of medical devices.
Haroon Atchia, CEO and co-founder of the London-based medical device regulatory consultancy Quality First International, has written a basic guide that helps medical device manufacturers to establish the status of technical standards used in the medical device industry and how they may be applied, how to evaluate a standard and – perhaps most importantly – how to provide evidence necessary to demonstrate conformity and limits conferred.
Taken from introductory and intensive training courses developed by Quality First International, and systems, procedures and activities created and implemented for numerous client medical device manufacturers, it is hoped this basic guide can provide readers with quick and simple insight into the world of technical standards used in the medical device industry.
“The guide is presented in a question and answer format to reflect the types of questions commonly asked by medical device manufacturers during our training courses”, states Haroon Atchia. “In addition there are a few Q&As that are not immediately obvious to allow introduction and quick access to the subject.”
The guide has been published by Global Regulatory Press and may be purchased directly from their Bookstore, price: £65 (plus VAT as applicable).