Assuric gives you the eQMS, document control and audit tools to get ISO 13485 certified, all in one place.
Trusted byquality teams
Features
Complete eQMS
Manage your controlled documents, procedures and records in one place. Version control, review workflows and locked approved versions keep you audit-ready, without the folder sprawl and lost sign-offs.
Document & record control (21 CFR Part 11)
Approval workflows, full version history and FDA 21 CFR Part 11 compliant e-signatures. Every document has a clear owner, a review date and an audit trail.
Medical device risk management
Run your medical device risk management alongside your QMS. Record hazards, causes and controls, and link them to your technical documentation so your risk file and your quality system stay in step.
Document & policy management
Moving off a manual, audit-unfriendly tool? Bring your documents across with their version history and metadata intact, and pick up where you left off.
Benefits
Reuse controls and evidence across ISO 13485, ISO 14971, IEC 62304 and your clinical safety work. ISO 13485 is the quality system the others plug into, so a record written for one counts towards the rest rather than being rewritten for each.
Each document carries its own approval history table showing every version, who reviewed it, who approved it and when. Review and approval steps are configured per document, so the right people sign off on the right things, and the record builds itself as they do.
Start from a full ISO 13485 document set already mapped to the clauses it satisfies, with smart placeholders pulling in your systems, suppliers and named roles.
We connect you with audit partners who work directly in your workspace, so there's no evidence pack to assemble, no document dump and no back-and-forth over email. They see the current state of your QMS and audit against it, and the findings land as tracked actions rather than a PDF.
Frameworks
Overlapping requirements and evidence are mapped across frameworks automatically, so you never do the same work twice.
“We couldn't speak highly enough of both the Assuric team and the platform itself, which is incredibly easy to use, and with the skill and hardworking nature of the Assuric team. They've been a key component in accelerating our progress and deployments!”
Maks Kozarzewski
COO, VitVio
“The Assuric platform is a game changer in the clinical risk management field. It has been carefully designed to make the job of a CSO significantly more streamlined. The team are excellent and responsive to any product suggestions I have requested, and it has been a pleasure to work with them.”
Paul Llewellyn
CCIO, Accenture
“Assuric has been fantastic in helping us quickly and safely navigate regulatory compliance in the UK. From completing Cybersecurity requirements to DSPT, DCB0129, and DTAC, the team was supportive, extremely knowledgeable, and the platform made everything quick and straightforward. A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!”
Katie Baker
Director UK & Ireland, Tandem
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. A notified or approved body will expect a compliant QMS before granting a UKCA or CE mark for anything above the lowest risk class, and NHS and enterprise buyers increasingly ask for it during procurement. 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 device above the lowest risk class, it is the quality system notified and approved bodies will expect to see. 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.
ISO 13485 is the quality system the other standards plug into. Do the work once on 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.
Customisable procedures and policies written to pass audit, without the twenty-page design control documents you get elsewhere. Start from a sensible baseline and make it yours.
Talk to us about your eQMS, from document control to audits, built for device teams.
