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. If you would like to learn more about FDB's solutions, please click here.

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