The European Commission last week issued guidance addressing how manufacturers should prepare for the gradual roll-out of Eudamed called for in recent amendments to the Medical Device Regulations (MDR ...
The European Commission on Friday released three documents, including two on the Medical Device Regulation (MDR) and the In Vitro Diagnotic Regulation (IVDR) and what data from the unique device ...
New solutions deliver enterprise-grade data access and streamlined EUDAMED compliance, driving smarter, faster decisions across the business Rimsys, the global leader in Regulatory Information ...
A mandate for manufacturers to register their devices or in vitro diagnostics (IVD) in a new database for medical devices in Europe is on the horizon. The European Commission (EC) has outlined six ...
PITTSBURGH--(BUSINESS WIRE)--Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated ...
On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED ...
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