2-Day Medical Device Studies Training Course: Regulatory Requirements and Adverse Event Reporting (Online: Sept 17th-18th, 2026)

The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting (Sept 17th - Sept 18th, 2026)" training course has been added to ResearchAndMarkets.com's offering. Delve into the ...
MD&M East

Factors Influencing FDA Clearance Time for Medical Devices: Evolution of a Critical Regulatory Pathway

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...
360Dx

European Medicines Agency Commences Pilot Program for Breakthrough Medical Devices

During a third phase of the pilot, set to begin in the third quarter of 2027, the EMA will open the program to IVD makers and notified bodies.

Medical Device Regulations in Asia-Pacific Markets | 2-Day Online Training Course (Sept 16-17, 2026)

The "Medical Device Regulations in Asia-Pacific Markets (Sept 16th - Sept 17th, 2026)" training has been added to ResearchAndMarkets.com's offering. With the European medical device market now well ...
Medical Device and Diagnostic Industry (MD+DI)Opinion

The 1996 FDA Guidances That Sparked 'Stealth Regulation' Fears

MD+DI's Trivia Tuesday revisits the controversial 1996 FDA guidances that had some in the industry crying "regulatory ...
Regulatory Affairs Professionals Society

European Commission publishes implementing regulation on conformity assessments by notified bodies

The European Commission on Tuesday published an implementing regulation that outlines uniform quality management and ...
Regulatory Affairs Professionals Society

Euro Convergence: Experts discuss simplifying regulations while maintaining balance

Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the ...