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RD Biomed has successfully renewed its ISO 13485:2016 certificate, extending its validity until 13 August 2026.

This renewal comes after a thorough audit, underscoring RD Biomed’s unwavering commitment to maintaining the highest standards in the medical devices industry.

ISO 13485 is an internationally recognised standard tailored specifically for the medical devices sector. It applies to both medical device manufacturers and organisations that provide support to these manufacturers, emphasising the paramount importance of ensuring that medical devices consistently meet customer expectations and regulatory requirements.

isoTo obtain this certification, RD Biomed must demonstrate its dedication to establishing and implementing a robust quality management system in full compliance with ISO 13485 standards.

RD Biomed has earned a stellar reputation for its groundbreaking work in gastroenterology, particularly for its innovative product, Peptest. The ISO 13485 certificate covers various aspects of Peptest, including its design, development, manufacture, sales, and distribution, along with associated accessories. RD Biomed has held ISO 13485 certification since 2017.

Harvey Dettmar, director at RD Biomed, commented: “The ISO certification renewal reaffirms RD Biomed Limited’s steadfast commitment to upholding the highest standards within the medical device industry. It provides our customers with the assurance that Peptest consistently delivers a safe and effective solution.”

In addition to ISO 13485 compliance, Peptest also adheres to the European Directive 98/79/EC on in-vitro Diagnostic Medical Devices, as indicated by the CE mark of conformity.

This achievement underscores RD Biomed’s dedication to providing top-notch quality and reliability in their products. The certificate renewal sets the stage for continued excellence in medical device development, ensuring patient safety and global customer satisfaction.