Hi, I came across your post (from one year ago) while searching the forum today. The following webinar contains very helpful ...
Jeffery, I was hoping for Annual Report based on the below guidance. What did you end up doing? Cindy Guidance for Industry ...
Best practice includes early communication and negotiation about requirements at a high level. First the Marketing function ...
Thank you, Robert. Peter - as I stated, we are currently in Phase 3 so NDA has not been submitted yet. Plan is to list both ...
Hello Anon, StarFish Medical's Regulatory team can help you with this task. We have an internal Software Engineering team that ...
Hi Anon. I can help with you with this. I provide regulatory expertise for device manufacturers, including many software developers. ...
Hi Anon, would the main mode of action of the overall package depend on the MP or the MD? So for example, is this a combination ...
Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in ...
Could you speak with someone at the IRB that could advise on how it should be reported? ------------------------------ Pamela ...
------------------------------ Quality and Regulatory Specialist Morgantown WV United States ------------------------------
Either the content you're seeking doesn't exist or it requires proper authentication before viewing.
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