ISO 14971, otherwise known as the standard for Medical Devices – Application of Risk Management to Medical Devices has recently been updated.
This greatly improves the power and guidance for medical device inspection, something that is key to maintaining the usefulness and getting the best out of medical devices. ISO 14971 complements ISO/TR 24971, Medical Devices – Guidance on the Application of ISO 14971, a companion explainer to the former mentioned standard in outlining the truly best practice in the industry. Where both of these documents shine is in their integration with paperless inspection solutions, and the recent update to ISO 14971 has ensured that digital inspectors can once again make the most of medical device inspection. Reducing and managing the operating risks to medical device is not just the goal of the industry standard, but is highly important for both the operator, medical organisation and recipient of the medical examination/procedure.
Improving medical safety sounds like an obvious thing that any medical organisation should aspire to, but without proper guidance it is difficult to understand what the right step is without something unfortunate happening. Thankfully industry standards such as ISO 14971 help outline for organisations exactly what they can do to improve the safety of their medical devices and reduce the risk for all actors involved. By specifying the terminology, principles for managing the risks associated with medical devices such as In Vitro Diagnostic products (IVD) or Software as a Medical Device (SaMD), the standard is a great help to anyone in the medical profession operating or managing the equipment.
Medical devices such as IVD or SaMD benefit from standards such as ISO 14971 only if they can be effectively applied to the medical device inspection. Without proper implementation it is useless to claim compliance with such a standard, as it undermines the medical device standard, trust in the operator or trust in the organisation. This is why many medical organisations are today choosing to inspect their medical devices through paperless inspection solutions. Standards such as ISO 14971 can be attached to checklists as reference material, alongside outtakes of operation manuals or useful notes that are needed for the specific machine.