• By ICR Secretariat
  • Posted Wednesday, August 8, 2018

The Challenges of Conducting Medical Device Studies


The Challenges of Conducting Medical Device Studies

Keith Summerhayes & Selvarajah Sivshankar

ICR Medical Device Subcommittee

The purpose of writing a monograph on medical device studies was to highlight the regulations that govern devices and address issues associated with the many types of devices that are on the market. It can be difficult to find the relevant guidelines, documents, standards and directives that contain information about devices. This monograph will do just that. It discusses the practical processes involved in the global conduct of studies, including regulatory approval and post-marketing studies. It also contains a glossary.

The ICR Medical Device Subcommittee members have spent a lot of their own time researching and writing this monograph, not an effortless task. With their varied expertise, they have managed to pull together a unique resource which will be a great reference to all those involved in medical device studies.  

Published 2007.


To Order:

Simply Call: 01628 501700 & quote The Challenges of Conducting Medical Device Studies


Fill out a formscan it to office@icr-global.org or send it to The Institute of clinical research,White Waltham, Maidenhead SL6 3JF


The cost of one copy is £9.99 postage included. However, for large quantities, simply call 01628 501700 or send an email regarding your enquiry to office@icr-global.org.