From classification to certification, Assuric holds your QMS, risk file and technical documentation for SaMD and AIaMD in one place, with device specialists alongside you.
Trusted bymedical device teams
Benefits
Your ISO 13485 QMS, ISO 14971 risk file, IEC 62304 software lifecycle records and technical documentation live in one place and link to each other, so your technical file assembles from evidence you already hold.
SOPs, document control, training records, CAPAs, supplier management and internal audits come pre-built to ISO 13485, ready to adapt to how your team actually works.
Trace every risk from hazard to control, verification and residual risk, linked to the design records and releases behind it, with your DCB0129 hazard log kept in step.
Capture IEC 62304 lifecycle records as you build, from requirements and design to verification and release, alongside the cyber security evidence UK and EU MDR expect, from secure development to penetration testing.
Assuric AI drafts SOPs and technical documentation, suggests changes against ISO 13485 and keeps records current, with every edit a tracked suggestion until it is approved and signed off.
Work through gap analysis, QMS, technical file and audit with device specialists alongside you, so you go into your approved or notified body assessment with one complete set of evidence.
Core modules
One quality system connecting documents, risk, quality events, suppliers and post-market surveillance.
Features
Everything behind a UK or EU MDR submission, and everything that follows it.
Complete eQMS
SOPs, training records, CAPAs and internal audits pre-built to ISO 13485, with 21 CFR Part 11 compliant electronic signatures on every approval.
Technical documentation
The QMS, risk file and design records feed the technical documentation, so it assembles from evidence rather than starting again.
Quality events and CAPAs
Complaints, feedback and incidents from every source in one record, investigated and tracked through CAPA to closure.
Post-market surveillance
Surveillance activities, complaints and periodic review held with owners and dates, so nothing quietly lapses after approval.
Frameworks
Use intelligent automation to map overlapping framework requirements, reuse evidence and simplify compliance across multiple frameworks.
“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
Software intended for one or more medical purposes, such as diagnosis, prevention, monitoring or treatment, that performs that purpose without being part of a hardware medical device. In Great Britain it is regulated under UK MDR 2002, and in the EU and Northern Ireland under EU MDR 2017/745.
Under UK MDR 2002, much standalone software is Class I, but software that informs diagnosis or treatment can be Class IIa or higher. Under EU MDR, Rule 11 places software that informs diagnostic or therapeutic decisions in Class IIa or above, and in Class IIb or III where those decisions could lead to serious harm. Class I devices are self-declared and registered with the MHRA, while Class IIa and above need assessment by a UK Approved Body for UKCA marking or a notified body for CE marking.
ISO 13485 certification is not a legal requirement in itself, but for Class IIa and above an approved or notified body audits your quality management system, and ISO 13485 is the recognised way to meet that requirement. Under EU MDR, every manufacturer, including Class I, must have a quality management system.
IEC 62304 is the software lifecycle standard for medical device software. It covers development planning, requirements, architecture, verification, maintenance and problem resolution, with software safety classes A, B and C setting how much rigour each part of your software needs.
ISO 14971 is the risk management standard for medical device manufacturers under UK and EU MDR. DCB0129 is the NHS clinical risk management standard for health IT. A SaMD deployed in the NHS usually needs both, and Assuric keeps your risk file and hazard log in step, with shared controls and evidence.
Yes, if it has a medical purpose. AI as a medical device (AIaMD) is classified and regulated in the same way as other SaMD under UK MDR and EU MDR, with added expectations on training data, performance monitoring and how model changes are controlled. Assuric manages these AI-specific risks and controls inside your ISO 13485 QMS and ISO 14971 risk file.
Yes. End-to-end certification support is included, from gap analysis and setting up your ISO 13485 QMS to building your technical documentation and preparing for your approved or notified body audit, with device specialists alongside you throughout.
See how Assuric brings your QMS, risk file and technical documentation together, from classification to certification.
