British Standards Institute (BSI) publishes guidance on device standards:
This article was originally published in Clinica
Executive Summary
Guidance on the application of EN 29001/2 and EN 46001/2 for the active medical device industry, including active implantables, has been published by the British Standards Institute. Copies, at £45 (£22.75 to BSI members), are available from BSI Customer Services. Tel: +44 (181) 996 7000. Fax: +44 (181) 996 7001.