You are very welcome! Sent from my Verizon, Samsung Galaxy smartphone Get Outlook for Android
First, take a deep breath and make sure your emotions don't get the best of you and undermine your credibility in case there is a detail that you might be overlooking. Next, consider that, for the read more
Great information! ------------------------------
This message was posted by a user wishing to remain anonymous Thank you all for this valuable information. We are a foreign company and the sterilization is planned to be done in UK by the distributor. read more
This message was posted by a user wishing to remain anonymous In all the years that I have been in Regulatory Affairs, creating risk management files has always been the responsibility of QA. I am receiving 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 A manufacturer of medical devices is contemplating to sell the intellectual property and commercialization rights of a medical device to another company. However, the original developer will ...
This message was posted by a user wishing to remain anonymous A manufacturing company is being acquired through a process where the old company (OLD-comp) will no longer exist while a new one (NEW-comp) is created to continue doing the same manufacturing ...
This message was posted by a user wishing to remain anonymous Hi all, Does anyone know what the labeling requirement for a class I SiMD in EU? Would we need a separate software UDI to be applied in the software if a UDI is on the computer itself. ...
T here’s limited regulatory guidance on gene therapies for many drug manufacturer s and how i t can be a struggle to develop successful strategies for CMC. At this upcoming RAPS workshop , @Janmeet Anant will ...
The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological ...
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