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RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization.
Stay informed on the latest healthcare regulatory news through RAPS’ online magazine, Regulatory Focus and its companion daily e-newsletter RF Today, or by following RAPS on social media, including Twitter, LinkedIn and Facebook.
Reporters, bloggers and other members of the media interested in covering RAPS events or programs should contact Zachary Brousseau, senior manager of communications, at zbrousseau@raps.org or by calling +301 770 2920 ext. 245.
Posted 12 May 2022 | By Zachary Brousseau
RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years and drew more than 500 particip...
Posted 24 March 2022 | By Zachary Brousseau
Prominent officials from EMA, FDA, Swiss, Austrian and UK national health authorities, and several notified bodies will speak at the upcoming RAPS Euro Convergence. The annual three-day confer...
Posted 17 March 2022 | By Zachary Brousseau
FDA will continue its longstanding co-sponsorship of the MedCon conference. With a focus on fostering open discussions of the most pressing issues facing the medical device industry, the AFDO/...
Posted 10 March 2022 | By Zachary Brousseau
RAPS today announced the names of the 132 professionals who passed one of the two Regulatory Affairs Certification (RAC) exams in autumn 2021. By passing, they earn either the RAC-Drugs or RAC...
Posted 28 February 2022 | By Zachary Brousseau
RAPS and the Association of Food and Drug Officials (AFDO) have come together to support sharing, collaboration and learning across the global healthcare products community. With a focus on fo...
Posted 09 May 2022 | By Ariana Pelosci
Investigators identified that in pivotal clinical trials supporting FDA approvals of CAR T-cell therapies for patients with hematologic cancer, Black patients were significantly underrepresented.
Posted 06 May 2022
Stakeholders in a session at MedCon 2022 expressed largely positive sentiments about their experience with the US Food and Drug Administration’s (FDA) Digital Health Software Precertification (Pre-Cert) Program.
Posted 05 May 2022 | By Shawn M. Schmitt
The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
Posted 12 April 2022 | By Alan Condon
The FDA has issued two guidelines that make it less complex for medtech companies to commercialize orthopedic devices and sutures using its safety and performance-based pathway, according to the Regulatory Affairs Professionals Society.