RAPS

Medical Devices: EU Regulations

This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the ...
RAPS

Medical Devices: US Regulations

This course is intended to provide a basic overview of US medical device regulation. This course is intended to provide a basic overview of US medical device regulation. It covers a wide range of ...
Case Western Reserve University

Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath

The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Innovations in medical device technology hold 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 ...
JD Supra

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a ...
MD&M East

Navigating Medical Device Supply Chain Disruption

The medical device industry faces unprecedented complexity as regulatory frameworks continue to evolve while technological capabilities expand exponentially. As we progress through 2025, manufacturers ...