IVDR Certification service for in vitro diagnostic devices, ensuring regulatory compliance with EU In Vitro Diagnostic Regulation requirements. Comprehensive conformity assessment and quality management system certification for IVD manufacturers and distributors.
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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Shanghai JOYSUN Enterprise Management Technology Service Co.,Ltd. · China
Regulatory consulting services for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance in the European Union. Supports manufacturers with certification documentation, technical file preparation, notified body liaison, and post-market surveillance strategies to achieve CE marking and market authorization.
Precise testing & Certification(Guangdong)Co., Ltd. · China
Third-party certification and testing services for medical devices and in vitro diagnostics. Provides regulatory compliance assessment, documentation review, and certificate issuance to support market authorization and quality assurance requirements.
Maven Profcon Services LLP · India
Regulatory consulting services supporting medical device and IVD manufacturers through CE marking, FDA 510(k) clearance, and UKCA certification processes. Assists with technical documentation, clinical evaluation, risk management, and conformity assessment to meet EU MDR, EU IVDR, and UK regulatory requirements.
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