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 ...
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IETQAN Conformity and Certification
Cairo, Egypt
IETQAN believes in perfection, and it s not just a name for us; it s our core driver and the code we strive to uphold. Our logo represents the DNA as a symbol of a perfect object, which is what we aim to achieve in everything we do. As an ISO 17025, ISO 17020, ISO 17021 accredited service provider, we ensure that our services meet the highest standards of quality, accuracy, and reliability. Deliver activities that meets the regulatory requirements in ever increasing demanding regulatory environment is key target for our team. Our team of experts is dedicated to providing you with outstanding service, and we strive to exceed your expectations every time IETQAN is proud to offer testing, validation, and technical services to the Medical Devices Pharmaceutical Sectors throughout Egypt and the area. With more than 1500 assignments, and our reports have been reviewed and accepted by many regulatory authorities and noticed bodies.
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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.
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.
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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