Answered By: Poping Lin Last Updated: Sep 29, 2016 Views: 174
Global Medical Device Regulation
K3611.M45 G56 2012 in the Stamps Reading Room Core Collection
This book by the Regulatory Affairs Professionals Society (RAPS) is intended as a source of information on medical device regulations in the international arena, based largely on Global Harmonization Task Force and ISO requirements, and regulation s in the US, EU, Canada and Japan. It is both for those who are new to the field and experienced professionals working in multiple markets.
- See free Videos and pre-recorded webinars or Medical Device Regulatory Process Charts and Approval Timelines by Emergo Group which differ by country.
- US Device Approvals, Denials, and Clearances by FDA.