Qase3D introduces MDR system form hospital 3D labs - a practical, legally grounded path to MDR compliance for Point-of-Care ...
Catania, Italy, December 12th, 2025, FinanceWireNTA Implant (Pilatus Swiss Dental GmbH), the Swiss-origin, MDR-certified ...
Lawmakers requested the report after a 2023 ProPublica and Pittsburgh Post-Gazette investigation revealed that the FDA had ...
Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its certification under the EU ...
The "The EU Regulations for Digital Medical Devices with AI Components - A Basket Full of Requirements - What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ...
Medical Device Network on MSNOpinion
UK reforms highlight the case for digital submissions in medical device regulation
Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, discusses the potential of digital submissions to ...
The "The EU Regulations for Digital Medical Devices with AI Components A Basket Full of Requirements What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ...
This article captures the differences in regulations in post-marketing safety surveillance in drug device combinations in the US and the EU. Drug-device combinations have improved the landscape of ...
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 ...
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