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...
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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BSI Group Ltd. · United Kingdom
ISO 13485 certification service for medical device manufacturers ensuring compliance with international quality management standards. BSI provides accredited certification and auditing to establish safety, efficacy, and regulatory acceptance of medical devices across global markets.
IETQAN Conformity and Certification · Egypt
ISO 13485:2016 certification validates that medical device manufacturers have established and maintain a compliant quality management system. This certification demonstrates adherence to international standards for design, production, installation, and servicing of medical devices, ensuring product safety and efficacy throughout the device lifecycle.
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.
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