See matching posts in thread - MDR Consultant...Good morning, I w...
Good morning, I would like to solicit someone to help my company during the MDR gap analysis, specifically the Clinical part
Hello, I am working to assess our materials for compliance to EU MDR 2017/745, specifically Annex I Section 10.4 which gets into EC 1272 and EC 1907
See matching posts in thread - EC 1272 / EU MDR Question...Hello,...
MDSS is having two 1-day workshops on the MDR (July 27) and the IVDR (Aug 3) in Chicago
See matching posts in thread - MDR/IVDR Workshop in Chicago...MDS...
A question regarding IFUs on the manufacturers website? Is this required per: (GSPR 23.1) "the instructions for use… shall, if the manufacturer has a website, be made available and kept up to date on the website."
See matching posts in thread - EU MDR - Manufacturer IFU on We...
Hi Allyson, See my comments below I am looking for assistance on: a) can I use that statement from the supplier to justify out of needing the toxic substance symbol/IFU warnings and info related to the substances, and/or is there some sort of assessment/testing I need to do to prove these...
Can anybody answer if the RAC devices exam now refers to EU MDR (for the EU Regulations) and NOT the MDD/AIMDD?
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
JoinMy RAPS DashboardLearn More
About UsTerms of UsePrivacy Policy