EU MDR Certification service for medical devices ensures compliance with European Medical Device Regulation requirements. This certification validates product safety, performance, and quality management systems for market authorization in EU member states.
Manufactured by
IMQ Certification (Shanghai) Co., Ltd.
China
IMQ is a major European one-stop testing and certification service center with 30 years of experience in medical device testing. The company holds ISO 17025 accreditation, CB Testing Laboratory certification, and is a Notified Body for EU MDR 2017/745 and IVDR 2017/746. IMQ is the only Italian organization recognized as an Auditing Organization for MDSAP, enabling medical device exports to the USA, Canada, Brazil, Japan, and Australia.
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Applus+ Laboratories
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Applus+ Laboratories · Spain
EU Medical Device Regulation (MDR) certification service enabling manufacturers to demonstrate compliance with European regulatory requirements for medical devices. This certification validates product safety, performance, and quality standards necessary for market authorization and commercialization across EU member states.
Ente Certificazione Macchine Srl · Italy
EU Certification service for medical devices under Regulation (EU) 2017/745 (MDR). Provides comprehensive quality and safety assessment, documentation review, and regulatory compliance support to enable market authorization throughout the European Union. Essential for manufacturers seeking to demonstrate conformity with current EU medical device regulations.
INTERTEK GROUP PLC · China
CE Certification service for medical devices under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). Enables manufacturers to demonstrate compliance with EU regulatory requirements for market authorization. Includes conformity assessment, technical documentation review, and quality management system evaluation.
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