RD Biomed has achieved the highly-coveted ISO 13485: 2016 certification.
ISO 13485 is an internationally agreed standard specific to the medical devices industry.
Achieving this ISO certification indicates RD Biomed Limited meets the highest standards required of quality management in the medical device industry.
To achieve ISO 13485 certification, we needed to demonstrate our ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
RD Biomed – led by Professor Peter Dettmar – specialises in healthcare product development in gastroenterology, including Peptest. The approval is applicable to the manufacture, sales and distribution of our reflux diagnostics device Peptest, including associated accessories.
Professor Peter Dettmar, director at RD Biomed, said: “This is fantastic news for RD Biomed and a brilliant accomplishment for our team in achieving this significant milestone. ISO certification can give customers confidence in our ability to consistently bring safe and effective products to market.”