We’re pleased to announce that we have achieved the highly-coveted ISO 13485: 2016 certification.
ISO 13485 is an internationally agreed standard specific to the medical devices industry.
To achieve ISO 13485 certification, RD Biomed – the Hull-based medical technology company behind Peptest – needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The approval is applicable to the manufacture, sales and distribution of Peptest, including associated accessories.
RD Biomed – led by Professor Peter Dettmar – specialises in healthcare product development in gastroenterology, including Peptest.
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.”
Andrew Woodcock, laboratory manager at RD Biomed, also commented: “Achieving this ISO certification indicates RD Biomed Limited meets the highest standards required of quality management in the medical device industry.”
RD Biomed has already achieved the ISO 9001:2008 certification – the global benchmark for quality management – and Peptest conforms to the European Directive 98/79/EC on in-vitro Diagnostic Medical Devices, which is shown by the CE mark of conformity.