Please feel free to contact me at ranjit@kitemedicaltech.com. I will ensure your needs are met within your budget. I am a former BSI auditor and exactly know what auditors are looking for. Regards, read more
This message was posted by a user wishing to remain anonymous I agree with everything Richard posted, but I wanted to add some addition information. IDEs are approved/disapproved on the basis of safety read more
This message was posted by a user wishing to remain anonymous May be superseded by the IMDRF documents - see App A? https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech- read more
This message was posted by a user wishing to remain anonymous I agree with Richard. It is 30 days. FDA can convert so you need another 30-day review, but that doesn't happen very often anymore. In a read more
This message was posted by a user wishing to remain anonymous Hello dear colleagues, We are currently developing a process for transferring regulatory requirements from standards, regulations and guidelines read more
View this profile on Instagram RAPS (@regulatoryprofessionals) โข Instagram photos and videos
RAPS (@regulatoryprofessionals) โข Instagram photos and videos
This message was posted by a user wishing to remain anonymous In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA ...
This message was posted by a user wishing to remain anonymous Greetings! My small/mid-sized organization is interested in developing a software application for spatial tracking of a device (likely product code OLO ). As we have never developed such ...
This message was posted by a user wishing to remain anonymous Hello dear colleagues, We are currently developing a process for transferring regulatory requirements from standards, regulations and guidelines into product-related requirements. ...
Dear Colleagues, I am seeking confirmation on the following queries regarding the forthcoming Windsor Framework regulation: Will the regulation require changing the testing and batch release activities currently performed in Ireland to Northern ...
This is a great opportunity for those looking for positions within FDA and even those just wanting to spruce up their resume! DC/Baltimore Area Chapter Virtual Event: Tools and Tips To Enhance Your FDA Career Application| RAPS ------------------------------ ...
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