Every framework, mapped once
Track NHS, CQC, data protection, security, medical device and international frameworks side by side, with requirements and evidence mapped across them so nothing is done twice.
All-in-one compliance, built for healthtech
The only platform that covers international data protection, cybersecurity, NHS, medical device and healthcare provider compliance in one place.
- Fully integrated QMS, ISMS and AIMS
- Data protection, cybersecurity, NHS and CQC compliance
- International coverage, including UK, US and EU
Trusted byhealthtech teams
One platform for
all healthtech compliance
Clinical safety from hazard to safety case, spreadsheet-free
Assuric · Hazard log
HAZ-017 logged · Incorrect dose displayed after unit conversion. Initial risk 12 High
Controls added · Unit validation, second-clinician check. Residual risk 4 LowClinical Safety Case Report updated · DCB0129
Data protection and security built for sensitive healthcare information
ISO 27001
SOC 2
DSPT
NHS DTAC
GDPR
DCB0129
Cyber Essentials
ISO 13485
Access control policyMapping to frameworks4 frameworks updated
Clinical governance without the pre-inspection panic
Assuric · Incidents
Policy reviews2 reviews dueAll policies current
ROSafeguardingReview dueCurrent
JMIncident reportingCurrent
TBConsentReview dueCurrent
SaMD, AIaMD & QMS, certify as fast as you ship
Assuric · Product classification
Classification
Software intended for diagnosis or treatment decisions
Pending
Class IIa
UK MDR · Rule 11
Quality ManualISO 13485
Design and Development PlanISO 13485
Risk Management FileISO 14971
Clinical EvaluationISO 13485
Post-market Surveillance PlanISO 13485
NHS compliance getting you ready for deployment
Assuric · Trust Centre
Evidence requestedCollecting 4 items4 of 4 shared to Trust Centre
DTAC formRequested
DSPTRequested
ISO 13485 certificateRequested
People trainingRequested
Features
One-stop-shop for digital health compliance
QMS, ISMS and AIMS in one workspace
Run your quality, information security and AI management systems together, sharing documents, risks and evidence instead of maintaining three separate systems.
AI and automation that do the busywork
Agentic workflows, AI drafting and MCP read and write access keep records current and tasks moving, with full activity logs and enterprise-grade security keeping you in control.
One place for every document and record
A built-in AI-native document editor and evidence repository hold your policies, risks, evidence and compliance work, all linked and version controlled.
Ready for procurement
Share your compliance position through your Trust Centre and answer security questionnaires with AI, so NHS and enterprise procurement keeps moving.
Experts on hand when you need them
Named CSOs, DPOs and regulatory specialists can work inside your workspace through our expert support, from onboarding through to certification and audit.
Every framework you'll ever need
Use intelligent automation to map overlapping framework requirements, reuse evidence and simplify compliance across multiple frameworks.
Benefits
The compliance platform you won't outgrow
One system for all compliance
Start with the frameworks you need now and add more as you grow, from NHS and CQC to data protection, security, medical devices and international markets, reusing evidence instead of starting again.
Spend less time on manual work
AI, automation and live integrations take care of the repetitive work, from drafting documents to monitoring security, so your team can focus on building.
Be audit-ready all year round
See where you stand across every framework at any moment, with reporting views and Slack alerts so you never miss a deadline or a review.
Build trust with buyers and partners
Show NHS buyers, enterprise customers and partners a mature, well-evidenced approach to compliance, with everything they ask for ready to share.
Built for digital health
Built by NHS doctors, certified clinical safety officers, technology experts and software as a medical device regulatory specialists.
Comprehensive onboarding
Hand over your existing documentation and we’ll map and upload all of it against your requirements.
Trusted by healthtech’s very best
“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
Frequently asked questions
It depends on who you sell to. Selling into the NHS usually means DTAC, which covers clinical safety (DCB0129), data protection (GDPR and DSPT) and cyber security (Cyber Essentials). Private healthcare is normally GDPR and Cyber Essentials. If your software influences clinical decisions you will also need MHRA registration and, above Class I, an ISO 13485 quality management system.
Alongside UK frameworks, Assuric covers international standards such as SOC 2, HIPAA, EU MDR, ISO 27001, ISO 13485 and ISO 9001, with evidence mapped across them so you can expand into new markets without starting again.
It’s all three. Assuric includes a document editor, a library of policies and SOPs, version control, approval workflows and 21 CFR Part 11 compliant e-signatures, so your ISO 13485 quality system, ISO 27001 information security management system and ISO 42001 AI management system live in the platform rather than in exported files alongside it.
Yes. Most teams start with what their first buyers ask for, often DTAC or Cyber Essentials, and add frameworks as they grow. Evidence you’ve already collected is mapped to each new framework, so you only fill the gaps.
Yes, and most customers do a mix. We bring your existing documents in during onboarding, map them to the frameworks they satisfy, and use our templates only for the genuine gaps.
It depends on which frameworks you need and how much documentation you already have. GDPR and Cyber Essentials are usually the quickest, while DTAC and medical device registration take longer. Whatever you’re working towards, Assuric gets you there at least twice as fast as doing it manually, because the platform shows you exactly what’s needed, reuses the evidence you already have and drafts much of the documentation for you.
Every software plan comes with extensive support to get you compliant, from onboarding and mapping your existing documentation to guidance on what each framework needs and help from our team whenever you need it. Dedicated consultancy and named roles, such as a Fractional CSO or Fractional DPO, are available as additional services.
No. Several customers keep a general GRC tool for their US and information security work and use Assuric for the NHS, clinical safety and quality side. During onboarding we import or link what you have already evidenced and map it across the UK frameworks, so nothing is duplicated.
A consultancy is limited by how many people it has. Assuric is technology first with the consulting built in, so the platform tells you what is needed and our clinical, regulatory and data protection specialists work through it with you inside the same system.
All-in-one compliance that
speaks healthcare
See how Assuric can help you manage every framework, document and record, all in one place.