Regulator-approved AI models used in eye care vary widely in providing evidence for clinical performance and lack ...

Learn key considerations for data selection for AI-driven MedTech development and how to identify the ideal data sets.

The introduction of the Person Responsible for Regulatory Compliance (PRRC) role mandated under the Medical Device Regulation (MDR) 2017/745 and the In-vitro Diagnostic Device Regulation (IVDR ...

The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" training has been added to ...

As these technologies evolve, ASEAN countries face an urgent need to harmonize regulations to address shared challenges, he noted. To that end, the Indonesian Health Ministry, Japan’s PMDA, and the ...

Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with ...

“Senate Bill 25-003, in its current form, could severely impact these sectors by introducing regulations that would limit access to outdoor recreation, diminish local tourism, and harm the ...

He'd also like to see more regulation, training, certifications and other safety protocols. Peters would like to see that, too. "Let's do the right thing," Peters said, suggesting that state and ...