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.
Manufactured by
BSI Group Ltd.
Milton Keynes, United Kingdom
We guide you on your journey to meet global standards, promote safety, and enhance trust with your clients. As the world's first national standards body, our unrivalled global expertise and long-standing commitment to public benefit and innovation sets the benchmark for regulatory excellence. Our comprehensive portfolio offers you a wide range of proven regulatory and quality management services to support you in bringing compliant devices to market efficiently and safely. CE certification UKCA Certification ISO 13485 certification MDSAP Certification – Medical Device Single Audit Program and many more specialized solutions tailored to your regulatory needs.
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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.
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.
TS Quality & Engineering SRL · Italy
Comprehensive certification and auditing support for medical device manufacturers seeking ISO 13485, ISO 9001, and ISO 27000 compliance. Services include quality management system development, regulatory documentation, risk management, and design control to facilitate market introduction of medical devices globally.
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