FDB (First Databank) Achieves ISO 13485:2016 Certification - Quality Management System for Medical Devices

First DatabankFDB (First Databank) 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. If you would like to learn more about FDB's solutions, please click here.

About FDB

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.

Most Popular Now

Northern Lincolnshire and Goole NHS Foun…

Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) has launched new NHS App features to transform the way patients access and manage their appointments within the NHS. The programme, known...

Genomics England Deploys Sectra Imaging …

Genomics England has completed installation of an enterprise imaging system that will help to support a world-pioneering initiative for cancer research. The programme is linking whole genome sequencing, pathology and...

Orion Health Strengthens French Business…

Orion Health is strengthening its presence in France with the appointment of digital health industry heavyweight, Tristan Debove, to lead its operations. Tristan Debove has more than 25 years of experience...

AI Approach may Help Detect Alzheimer's …

Although investigators have made strides in detecting signs of Alzheimer's disease using high-quality brain imaging tests collected as part of research studies, a team at Massachusetts General Hospital (MGH) recently...

AI Predicts Cancer Patient Survival by R…

A team of researchers from the University of British Columbia and BC Cancer have developed an artificial intelligence (AI) model that predicts cancer patient survival more accurately and with more...

Virtual Reality Games can be Used as a T…

Virtual reality gamers (VR game) who finished it faster than their fellow gamers also have higher levels of general intelligence and processing capacity. This was the result of a study...

Will Future Computers Run on Human Brain…

A "biocomputer" powered by human brain cells could be developed within our lifetime, according to Johns Hopkins University researchers who expect such technology to exponentially expand the capabilities of modern...

Detecting Anaemia Earlier in Children Us…

Researchers at UCL and University of Ghana have successfully predicted whether children have anaemia using only a set of smartphone images. The study, published in PLOS ONE, brought together researchers and...

AI can Help Optimize CT Scan X-Ray Radia…

Computed tomography (CT) is one of the most powerful and well-established diagnostic tools available to modern medicine. An increasing number of people have been opting for CT scans, raising concerns...

Study Reveals Smartphone Spyware Apps ar…

Smartphone spyware apps that allow people to spy on each other are not only hard to notice and detect, they also will easily leak the sensitive personal information they...

Orion Health Appoints Mark Hindle as Vic…

Orion Health has appointed Mark Hindle as its new vice president for the UK and Ireland. Mark has joined the leading supplier of digital tools to improve healthcare experience from...