Meet every requirement for
ISO 13485 with Assuric compliance software

ISO 13485 is the international standard for a quality management system (QMS) specific to medical devices. It sets out how you design, build, document and maintain a device to a consistent, safe and traceable standard. For medical device software it is the foundation most regulators and buyers expect to see.

It is not a legal requirement in its own right, but in practice it is close to essential. Under the EU MDR every manufacturer needs a QMS, and from Class IIa upwards a notified or approved body assesses it before granting a CE or UKCA mark. NHS and enterprise buyers increasingly ask for ISO 13485 during procurement. In the US, the FDA’s Quality Management System Regulation, in force since February 2026, incorporates ISO 13485 by reference. Even for a Class I self-certified device, an ISO 13485 QMS is the cleanest way to evidence that you build safely.

ISO 13485 is for organisations that design, make or service medical devices, including software as a medical device. If you plan to get a UKCA or CE mark for a Class IIa device or above, it is the standard notified and approved bodies expect your quality system to meet, and under the EU MDR even Class I manufacturers need a quality system. NHS and enterprise buyers may ask for it too.

ISO 9001 is a general quality management standard for any organisation. ISO 13485 is built on the same foundations but tailored to medical devices, with far more emphasis on regulatory requirements, risk management, traceability and documentation. If you make a medical device, ISO 13485 is the one that matters.

They work together. ISO 13485 is your overall quality system, ISO 14971 is how you manage risk, and IEC 62304 covers your software development lifecycle. Assuric lets you manage all three in one place and reuse evidence across them.

Yes. ISO 13485 is the quality system the other standards plug into, including ISO 14971, IEC 62304 and ISO 27001. Do the work once in Assuric and reuse it across all of them.

It depends on your product and where you are starting from, but the documentation is usually the bottleneck. Assuric shortens that part significantly with ready-to-use templates and a structured QMS, so most teams move faster than they expect. We also work with excellent notified and certification bodies, so when your documentation is ready your audit is with people we know and trust. Book a demo and we will give you a realistic timeline for your device.

An ISO 13485 certificate is usually valid for three years. Your certification body carries out surveillance audits in between, then a recertification audit at the end of the cycle. Assuric keeps your controlled documents, internal audits and corrective actions in one place, so your QMS stays ready for each visit.

Yes. Customisable procedures and policies written to pass audit, without the twenty-page design control documents you get elsewhere, so you start from a sensible baseline and make it yours.