FDB (First Databank) achieves ISO 13485:2016 certification – Quality Management System for medical devices

FDB (First Databank) today announced that it has achieved ISO 13485:2016, the Quality Management System (QMS) for medical devices. This is a significant step for FDB, the UK’s leading supplier of prescribing decision support solutions and it paves the way for the company’s journey towards up-classification of its solutions.

FDB’s solutions are integrated into healthcare systems across a wide range of settings and enable evidence-based prescribing by providing essential checks to support clinicians. ISO 13485:2016 is a widely recognised and globally defined QMS, specific to medical devices, which is audited independently on a regular basis. ISO is the International Organization for Standardization, which develops and publishes international standards.

FDB already operated a QMS significantly above ISO 9001 but was keen to enhance policies and procedures to better serve their customers, clinicians and patients. The Compliance team at FDB worked intensively over 18 months with SGS United Kingdom Ltd to achieve certification. The work involved further strengthening FDB’s existing focus on quality by making sure enhanced quality controls existed at every stage of every process.

Sarah Dransfield, Information Governance Manager, FDB says: 'As FDB’s medical data and solutions are used in the care and treatment of patients, it is vital that we do everything to ensure that our systems, solutions and data are both as safe as possible, and compliant with all relevant laws and regulations.’

Darren Nichols, Managing Director, FDB says: ‘We are so proud of the whole team at FDB who have worked so hard to achieve this certification. It’s a significant step to go from ISO 9001 to ISO 13485:2016, which has brought about a hugely positive culture change. In a patient safety driven business, we believe adherence to this higher standard, required for medical devices, is vital and means that the necessary policies and procedures are in place to enable FDB to deliver clinical decision support products of a consistently higher quality.’

FDB achieved ISO 13485:2016 in January 2023 under certificate number: GB23/00000056 with SGS United Kingdom Ltd.

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For further information, please contact suzie@castlegatecommunications.co.uk or call 0772 999 3721. 



FDB (First Databank) creates and delivers the world’s most powerful drug knowledge that ignites, inspires, and illuminates critical medication decisions. We collaborate with our partners to help improve patient safety, operational efficiency, and health outcomes. Our solutions drive healthcare information systems that serve the majority of hospitals, GP practices, pharmacies and many other areas of healthcare and are used by thousands of clinicians every day. For a complete look at our solutions and services, please visit the FDB website, or follow us on LinkedIn and YouTube.