Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, discusses the potential of digital submissions to benefit manufacturers, regulators, and patients.

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's global reach. The ...

The European Union has released two significant guideline changes to expand its medical device framework, updating the classification rules for medical device software to include app platform ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the Food and Drug Administration (FDA) took a more active approach to medical ...

Due to the increasing concerns about medical devices' cybersecurity risks, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic ...

LE MONT-SUR LAUSANNE, Switzerland--(BUSINESS WIRE)--Regen Lab, a global commercial-stage medical technology company specializing in the research, development, registration, manufacturing and ...

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 precision ...

GENEVA--(BUSINESS WIRE)--Medimaps Group, a Swiss/Global med-tech company specializing in image-processing software with AI capabilities for assessing bone health, announced today it received the ...

The medical device industry is undergoing a significant transformation as FDA transitions from the longstanding Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), ...

“The incoming administration has identified China and its manufacturing prowess as a key national security risk,” Meyercord said. “Many United States and Western companies have already, or will soon ...

According to BMI Research report, the global medical device market is projected to grow to $535.2 billion by 2024, indicating significant business opportunities with a compound annual growth rate of ...