Japan's consumption of medical devices makes it an attractive market for global medical device manufacturers. But manufacturers hoping to sell their devices in Japan must pay careful attention to the ...

The MDR 2017/745 came into effect in May 2021, replacing the former European Directives for medical devices (AIMDD 90/385/EEC and MDD 93/42/EEC). It is intended to establish a robust, transparent, ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

OSLO, Norway, May 8, 2025 /PRNewswire/ -- DNV, the independent assurance and risk management provider, has been recognized by the European Commission as a notified body for the certification of ...

PISCATAWAY, N.J.--(BUSINESS WIRE)--The first medical devices from companies including Ascensia have been certified under the new IEEE Medical Device Cybersecurity Certification Program. Test ...

MARTINEZ, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for ...

SANYO underlines a strong commitment to product design, quality and safety by becoming one of the first major international companies to gain Medical Device certification to European Council ...

KUALA LUMPUR, Oct 17 (Bernama) -- The Malaysian Standard Halal Medical Device certification should be strengthened to be widely accepted and recognised globally, the Malaysia Medical Devices ...