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.
Manufactured by
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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