Full Spectrum Services for Medical Device Manufacturers
Medical Device Serviceselena2021-09-08T18:45:46+00:00
Our Medical Device RA/QA Services
Celegence provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers.
Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.
EU MDR Gap Analysis
A comprehensive first step towards MDR compliance.
Manufacturers selling Medical Devices in Europe but located outside of Europe (3rd countries) need to appoint a Europe based Authorized Representative (AR) in order to place a medical device on the EU market as required by the new MDR 2017/745.
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