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COSMED's successfully transition to EU MDR requirements

Published: 31 October 2024

COSMED is pleased to announce its successful attainment of the European Medical Device Regulation (MDR) certification, a prestigious recognition granted by Kiwa Cermet Italia.

The certification underscores COSMED’s steadfast commitment to producing high-quality medical devices that fully comply with the European Union’s rigorous regulatory standards.

Achieving EU MDR certification marks a significant milestone for COSMED, reinforcing its dedication to excellence and its alignment with stringent European market requirements. This certification reflects COSMED’s focus on upholding superior standards in quality management, manufacturing processes, and product quality assurance.

Navigating the MDR’s demanding requirements involved months of strategic planning, rigorous preparation, and adherence to elevated standards. COSMED successfully overcame the complexities of multiple audits, simultaneous assessments, and challenges in notified body capacity to meet these new regulatory expectations.

By meeting the MDR standards, COSMED reaffirms its commitment to the safety and quality of its products throughout their design, manufacturing, and distribution. This achievement further strengthens the company’s position in the global medical device market, empowering it to continue advancing healthcare worldwide and enhancing its presence in the European market.

COSMED remains dedicated to providing healthcare professionals with dependable and innovative medical devices that elevate patient care and outcomes. This EU MDR certification stands as a testament to COSMED’s unwavering pursuit of excellence and its commitment to advancing industry standards.

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COSMED is a world leading supplier of Cardio Pulmonary, Metabolic and Body Composition testing solutions to Sports Science, Medicine, Professional Sport and Wellness.

COSMED is a world leading supplier of Cardio Pulmonary, Metabolic and Body Composition testing solutions to Sports Science, Medicine, Professional Sport and Wellness.

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