AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...

Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and ...

Applied Therapeutics (APLT) announced the appointment of Todd Baumgartner, MD, MPH as Chief Regulatory Officer. Dr. Baumgartner will serve as ...

The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based ...

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration ...

"Receiving this approval marks a significant milestone for Paragonix and Getinge, reinforcing our commitment to delivering innovative and regulatory-compliant medical devices,” said Dr. Lisa ...

SAN DIEGO, March 13, 2025 /PRNewswire/ -- DCN Dx, specializing in IVD CDMO and CRO services, has launched Regulatory Affairs Services, a new solution designed to help clients navigate complex ...