RD Biomed, a Yorkshire-based medical tech company, announced it has achieved ISO 13485:2016 certification.
To achieve ISO 13485 certification, RD Biomed needed to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
RD Biomed — led by gastrointestinal specialist, Professor Peter Dettmar — specialises in healthcare product development in gastroenterology, including a reflux diagnostic device, Peptest.
Andrew Woodcock, laboratory manager at RD Biomed, said: “Achieving this ISO certification indicates RD Biomed Limited meets the highest standards required 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 customers confidence in our ability to consistently bring safe and effective products to market.”
RD Biomed has already achieved the ISO 9001:2008 certification – the global 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.
