ISO 13485 Quality Management System certification for medical device manufacturers. This certification service ensures compliance with international standards for design, production, and distribution of medical devices. Czech Metrology Institute provides expert assessment and certification to valida...
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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Eurofins Electrical and Electronic UK Ltd · United Kingdom
ISO 13485 Quality Management System auditing and certification services for medical device manufacturers. Comprehensive QMS assessment, documentation review, and compliance verification across global regulatory standards. Supports device safety, efficacy, and market authorization requirements.
INTERTEK GROUP PLC · China
ISO 13485:2016 certification and training service for medical device quality management systems. Enables manufacturers to establish compliant QMS frameworks, document procedures, and train personnel to meet international regulatory requirements for medical device production and distribution.
IMQ Certification (Shanghai) Co., Ltd. · China
ISO 13485 certification validates that medical device manufacturers have established and maintain quality management systems compliant with international standards. This certification demonstrates organizational capability to design, produce, and deliver safe and effective medical devices. Essential for regulatory approval and market access across global healthcare markets.
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