Medical device companies face increasing pressure to bring products to market that meet strict safety and performance ...

BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Sesen today announced the launch of TrialS , a next generation regulatory ...

In February 2026, the medical device industry will be faced with new regulatory challenges that could shake up operations. The good news? Companies that are already in compliance with existing FDA ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies ...

AI in Healthcare Regulatory Affairs Market to reach USD 6.5 Bn by 2035 at 16.7% CAGR, driven by rising regulatory complexity and AI adoption.

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...

Rockville, MD, USA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- The Regulatory Affairs Professionals Society (RAPS) has published the updated, 10 th edition of Fundamentals of US Regulatory Affairs, the most ...

Labeling AI mental health chatbots as medical devices would stymie progress in helping people in need with simple tools that ...