RD Biomed is delighted to announce that it has renewed its ISO 13485:2016 certificate for three years following an extensive audit.
ISO 13485 is an internationally agreed standard specific to the medical devices industry. It applies to both manufacturers of medical devices and organisations that support medical device manufacturers, underpinning the duty of ensuring devices consistently meet customer and applicable regulatory requirements.
To achieve certification, RD Biomed needs to demonstrate its commitment to the development and implementation of a Quality Management System to comply with the ISO 13485 requirements.
RD Biomed – led by Professor Peter Dettmar – specialises in healthcare product development in gastroenterology, including Peptest.
The certificate covers the ‘design, development, manufacture, sales and distribution of the lateral flow device Peptest, including associated accessories’. RD Biomed has been ISO:13485 certified since 2017.
Professor Peter Dettmar, director at RD Biomed, said: “Renewal of this ISO certification indicates RD Biomed Limited continues to meet the highest standards required of quality management in the medical device industry. This can give our customers reassurance and the confidence in our ability to consistently offer a safe and effective product in Peptest.”
Peptest also conforms to the European Directive 98/79/EC on in-vitro Diagnostic Medical Devices, which is shown by the CE mark of conformity.
