The evolving EU MDR and IVDR present key opportunities for companies to enhance compliance strategies, engage with notified bodies, and optimize market access. Staying informed and proactively ...

Medical device makers use AI to turn EU regulatory challenges into competitive advantages via supply chain optimization.

There's no doubt that surgically implanted medical devices can improve lives. Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine ...

Registrar Corp., a unit of Paine Schwartz Partners, acquired Spanish medical device consulting services provider CMC Medical Devices, expanding the U.S.-based compliance specialist global reach.

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.

Registrar Corp aims to integrate its network with CMC’s offerings to help medical device companies in bringing products to ...

Please provide your email address to receive an email when new articles are posted on . EFORT believes that robust regulation to ensure a supply of safe devices and to monitor the introduction and use ...

The Government Accountability Office recently chastised the FDA for not moving fast enough in implementing stricter regulationsin approving Class III medical devices. In January, the Government ...

Artificial intelligence (AI) in health care is rapidly advancing beyond traditional applications. Autonomous AI agents are gaining significant attention for their potential to fundamentally transform ...

Richard Matthews is an elected member of The University of Adelaide Council, is an Additive Manufacturing consultant with the Entrepreneurship, Commercialisation and Innovation Centre at the ...

Learn what the recently released CDSCO draft guidelines for medical device software within India actually mean.

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...