Hi Anon, systems/procedure packs and Article 22 can be a little bit tricky (and for some reason NBs love to comment on them although in my opinion it is not their primary concern) so could you share read more
Hi Anon, when approaching the NB, did you ask for an MDR certification procedure or just for an ISO 13485 certification? Assuming that your software is higher than class I you will sooner or later need read more
Hi Joanna, like Richard I am not sure if I am getting the details correct, but as far as I can see: If you continued acting as a manufacturer after May 2021 and placed your devices on the market as read more
Hi Mauro, as far as I can see the medicinal product contributes the main mechanism of action so the combination package in my opinion can not be handled as a procedure pack under MDR Article 22 (as you read more
Let's take a different look at your question. How did you train / validate your software? I am sure by using (existing) footage of actual cases? And would that not qualify as data "from clinical source"? read more
View this profile on Instagram RAPS (@regulatoryprofessionals) โข Instagram photos and videos
RAPS (@regulatoryprofessionals) โข Instagram photos and videos
Hello, My name is João Nardo. I am a biologist from Brazil with 22 years of experience in business, regulation, and quality of medical devices. During my career, I have registered more than 200 products in the Latin American market and helped ...
In an effort to improve the quality of medical devices on the Chinese market, the NMPA, led by the National Institutes for Food and Drug Control (NIFDC), will do sampling inspections at various healthcare facilities. Sixty-six product types will be ...
Hello , We wanted to give this group an extra heads up about the upcoming Introduction to eCTD: Structuring Your First CTD-based Submission workshop happening 17-18 June . It’ll be informative and a great place ...
The NMPA CMDE recently issued a comprehensive technical review report, marking the fifth such report for overseas manufacturers this year . These reports are valuable resources for understanding NMPA technical and clinical reviewers' ...
Can we get a professional opinion on the impact (regulatory and/ or business) on IVD digital pathology manufacturers (not laboratories) following the amended FDA regulation regarding LDTs. ------------------------------ Ilan Sharon BSc Caesarea Israel ...
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