ProductMedical Services and Publications

Certification (conformity assessment) of medical devices according to Regulation (EU) 2017/745 (MDR)

Prague 4, Czech Republic

Conformity assessment and certification service for medical devices under EU Regulation 2017/745 (MDR). Provides expert evaluation to demonstrate that medical devices meet regulatory requirements for safety, performance, and quality standards before market authorization.

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Czech Metrology Institute

Prague 4, Czech Republic

Czech Metrology Institute offers: certification (conformity assessment) of medical devices according to Regulation (EU) 2017/745 (MDR) certification of QMS according to ISO 13485 top-level metrological services Czech Metrology Institute is listed as Notified Body 1383 in information system of European Commission NANDO. (https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1005068?organizationVersion=9)

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