Yorkshire medtech firm gets ISO 13485 for reflux testing kit

To achieve ISO 13485 certification, RD Biomed needed to demonstrate its ability to provide medical devices and related services that consistently meet client and applicable regulatory needs.

RD Biomed — led by gastrointestinal expert, Professor Peter Dettmar — specializes in healthcare product development in gastroenterology, including a reflux diagnostic device, Peptest.

Andrew Woodcock, laboratory manager at RD Biomed, said: “Achieving this ISO certification specifies RD Biomed Limited meets the highest standards essential of quality management in the medical device industry.”

Professor Peter Dettmar, director at RD Biomed, added: “This is fantastic news for RD Biomed and a brilliant accomplishment for our team in achieving this significant milestone. ISO certification can give clients confidence in our ability to consistently bring safe and effective products to market.”

RD Biomed has already achieved the ISO 9001:2015 certification – the worldwide benchmark for quality management. Its Peptest device conforms to the European Directive 98/79/EC on in-vitro diagnostic medical devices, which is shown by the CE mark of conformity.