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
Hello, for major guidances we perform a full documented gap analysis with scoring on every requirement (2 = compliant, 0 = not compliant, 1 = compliant, but improvements possible). In the gap analysis, read more
Hello, as Richard is mentioning, there are indeed several European countries with adapted UDI regulations, although I am not aware that there would be any request to have different GTINs, when the read more
Hi everyone, I think a viable training, well to be considered might be the ISO 13485 Training Course Ireland - IRCA Certified (complyguru.com) In my humble opinion, best report for quality/accreditation/price read more
Hello Anon, I am not aware of a country who requires a different GTIN, though UDI regulations are being implemented in other countries quite often and there are still bit of interpretation in countries 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