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.
The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
ZOLL, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the ZOLL AED 3 defibrillator is approved under the European Union (EU) Medical ...
LUND, Sweden, March 11, 2024 /PRNewswire/ -- Enzymatica's mouth spray ColdZyme® has received CE-certification under the new and more demanding European Union medical device regulation (MDR). This ...
Compliance with the Medical Device Regulation (EU) 2017/745 (MDR) presents many new challenges to Medical Device manufacturers. Our in-depth MDR training is designed to help you and your team prepare ...
GlobalData on MSN
Registrar Corp purchases Spain’s CMC Medical Devices
Registrar Corp aims to integrate its network with CMC’s offerings to help medical device companies in bringing products to ...
Starting from today, the new Medical Device Regulation (MDR) replaces the Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) in the European Union.
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