If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...

The Asian economy has experienced tremendous gross domestic product (GDP) growth over the past decade and is expected to continue at a healthy pace for the next several years. The medical device ...

EPA proposes some stricter PFAS rules for medical device makers, cutting reporting timeline from 6 to 3 months as companies ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

DUBLIN--(BUSINESS WIRE)--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" ...

As Medical Devices have continued to innovate, embedded software has grown. Software, artificial intelligence (AI), and machine learning (ML) are now a part of nearly every medical device. These ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

The Centre plans a major overhaul of India’s medical device regulatory framework by removing expiry-based licences and introducing perpetual approvals, along with standardised laboratory testing norms ...

DUBLIN--(BUSINESS WIRE)--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" ...