Every time there is a major public health scandal, governments respond with “new and improved” regulations. Such has been the case in the wake of the Poly Implant Prothèse breast implant scandal, in ...
Professionals have the opportunity to enhance their knowledge on the complex regulatory changes under the MDR and IVDR, gain insights into future developments, and understand their impact on market ...
Medical device development has moved to a model where regulatory compliance functions as a primary technical constraint. Engineering teams must treat global frameworks as specifications that dictate ...
The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...
In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
Opportunities lie in offering comprehensive training on global human factors and usability regulations for medical devices, focusing on user-centered design and post-market surveillance. This ...
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 ...
RAPS has teamed up with Meddev Solutions to offer The European Medical Device Regulation Guidebook. For anyone involved in ensuring compliance with the EU MDR, it is the ‘go-to’ reference and tool kit ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...