Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...

A medical device is an umbrella term for any instrument, software, or other article used alone or in combination for a medical purpose in humans. An estimated 2 million different kinds of medical ...

A review of the background, mission and statutory requirements of medical device regulation in the United States has been published. The report highlights the differences between regulation guiding ...

Dublin, Jan. 30, 2026 (GLOBE NEWSWIRE) -- 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 ...

Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy ...

In recent times, there has been an unprecedented level of public interest and active debate regarding the regulation of medical devices. Although medicines and devices are regulated under European ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

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 ...