Compliance
built for
healthtech
35+ frameworks in one platform. Map a control once and it satisfies every standard that asks for it.
- Flexible plans and frameworks
- Every framework, from SaMD to data protection
Trusted bycompliance teams
Every framework you'll ever need
Clinical safetyDCB0129
The NHS clinical risk management standard for manufacturers of health IT, covering the hazard log, safety case and Clinical Safety Officer sign-off.
Clinical safetyDCB0160
The companion standard for NHS organisations deploying health IT, so your customers can evidence their side of clinical safety.
NHSDTAC
NHS England's Digital Technology Assessment Criteria, the baseline every digital health product must meet before an NHS organisation can buy it.
Information governanceDSPT
The Data Security and Protection Toolkit, the annual self-assessment any organisation handling NHS patient data must publish.
SecurityCyber Essentials
The UK government-backed baseline for cyber hygiene, and a routine requirement in NHS and public-sector tenders.
SecurityCyber Essentials Plus
The same five technical controls as Cyber Essentials, independently tested by an accredited assessor.
Information governanceUK GDPR
The UK's data protection regime, enforced by the ICO, for any product processing personal data in Britain.
Information governanceEU GDPR
The EU's data protection regulation, for products serving patients or customers across the European Economic Area.
SecurityISO 27001
The international information security management standard, and the certification enterprise and NHS buyers ask for first.
Information governanceISO 27701
The privacy extension to ISO 27001 that turns your ISMS into a privacy information management system.
QualityISO 14001
The environmental management standard, increasingly requested in NHS tenders alongside net zero commitments.
Medical deviceIEC 62304
The software lifecycle standard for medical device software, setting safety classes and the development and maintenance processes that follow.
IEC 62366-1
The usability engineering standard for medical devices, covering use-related risk through to summative evaluation.
Medical deviceClass I MD (UK)
Registering your Class I device with the MHRA before it goes on the UK market, including the technical documentation behind your UKCA declaration.
Medical deviceUK MDR
The UK Medical Devices Regulations 2002 and the UKCA marking route overseen by the MHRA.
Medical deviceEU MDR
Regulation (EU) 2017/745 and the CE marking route for placing a medical device on the EU market.
Medical deviceMHRA SaMD
MHRA guidance on when software counts as a medical device in the UK, and which class it falls into.
Medical deviceClass IIa MD
Prepare Class IIa software as a medical device for UK Approved Body assessment, with QMS, risk file and technical documentation held in one platform.
Medical deviceISO 14971
The risk management standard for medical devices, from hazard identification through to residual risk acceptance.
QualityISO 13485
The quality management standard for medical device manufacturers, expected under both UK MDR and EU MDR.
QualityISO 9001
The general quality management standard, for teams that want a QMS without the medical device overhead.
QualityCQC
Care Quality Commission fundamental standards for providers delivering regulated care in England, including digital services.
QualityCQC Registration
The application to register with the Care Quality Commission before you deliver a regulated activity, with the policies and evidence it asks for.
AIEU AI Act
The EU's risk-based AI regulation, with most clinical AI landing in the high-risk tier and its documentation duties.
AIISO 42001
The AI management system standard for organisations building or deploying AI responsibly.
Information governanceHIPAA
US health data privacy and security rules, for UK healthtech companies expanding into American healthcare.
SecurityHITRUST
The US healthcare security certification that US health systems and payers often require from vendors.
SecuritySOC 2
The attestation US enterprise buyers ask for, mapped alongside ISO 27001 so you evidence both once.
QualityCustom
Bring your own standard and we'll map it.
Trusted by
healthtech’s very best
The best companies trust Assuric across all frameworks.
“A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!”
Katie Baker
Director UK & Ireland, Tandem
“The platform is easy to use, and the AI tools and automated reminders make previously dreaded compliance tasks a breeze.”
Kelly Klifa
CEO, Heim
“If you're looking for a partner who delivers at pace and makes compliance simple, Assuric is the one!”
Sarah Marsh
COO, Infix
“Assuric has genuinely changed the operational backbone of clinical safety for us.”
Dr Satya Raghuvanshi
VP Clinical, Accurx
“People take the mick out of me because all I do is talk about how good Assuric is. ”
Maria Rich
Digital Clinical Risk Manager, South Warwickshire University NHS Foundation Trust
Connect your existing tech stack
Claude, ChatGPT, Slack, GitHub, Jira, Linear, Copilot, Incident.io and the other tools your team and agents already use.
All of the evidence,
none of the busywork.
Explore AI & Integrations →Assuric MCP
Connect Claude, ChatGPT or any agent to your workspace. Read controls, draft policies, and update records, with every change logged.
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Agents + Automations
Agents monitor releases, controls and infrastructure. They flag risks and non-conformities and fix out-of-date records.
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Live integrations
Pull evidence straight from the tools you already use, so everything stays up to date. No exports, copy-paste, or old screenshots at audit time.
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Every framework,
one platform
Get in touch to learn more about how Assuric can help streamline and automate your compliance.