Add frameworks across SaMD, international requirements, ISO standards and more
Add frameworks at any time, with mapping across requirements and jurisdictions, so the controls you already evidence count towards each new one.
Compliance that
scales with you
Assuric handles compliance as you add products, frameworks and markets, so you can keep growing.
- One platform for every framework you need
- Full migration from your existing systems
- Continuous control and evidence tracking
- Fractional CSO and DPO support when you need it
Trusted by scalinghealthtech teams
Benefits
Built for scale-ups
Frameworks arrive pre-mapped
ISO 13485, IEC 62304 and UK MDR come mapped to controls you already evidence.
Evidence that enables full oversight
See every control, task and approval as it happens, so you always know where compliance stands across the business.
Manage compliance across all products
Product-specific tasks ensure you can map your compliance work across different products, jurisdictions and requirements. From a Class IIa device to a simple data management product, Assuric gives you full oversight.
Features
One-stop-shop for scale-ups
Six products doing the work a compliance team of several people would otherwise be doing by hand.
Automated compliance tracking
Track compliance across all frameworks
Control status across every framework you have live, the evidence behind each one, and what has gone out of date since you last looked.
All-in-one compliance
Manage all products in one place
Gain full oversight of all products, tracking key documents, risks and releases for each product.
Staff portal & training
Training records that survive an audit
Onboarding, training completion and competence per person, with acknowledgements tied to the version of the policy that was in force.
Clinical safety
A safety case that keeps up with releases
Safety case and hazard assessment kept current as the product changes, signed off by our Clinical Safety Officer acting as your named Clinical Safety Officer.
Frameworks
Every framework a scale-up gets asked for
Use intelligent automation to map overlapping framework requirements, reuse evidence and simplify compliance across multiple frameworks.
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
With Assuric, each control is mapped once across every framework you run, so one piece of evidence counts towards ISO 27001, DSPT, DTAC and others at the same time. When a new market or customer needs another framework, you switch it on and see straight away what is already covered and what is left to do.
Yes. We provide full migration and support to move your policies, records and evidence across from spreadsheets, document folders or another platform. Your team keeps working while we move it, and nothing is lost or re-papered.
Yes. Our Clinical Safety Officer can sign as your named CSO for DCB0129, and our Data Protection Officer can act as your named DPO. Both work inside your Assuric workspace, so sign-offs, incidents and data protection questions are handled where the evidence already lives.
Each product gets its own tasks, documents and risks, from a Class IIa device to a simple data product. You can see where compliance stands for each product and for the business as a whole, without keeping separate systems.
Usually when larger NHS trusts, enterprise customers or US buyers start asking for it in procurement. Because your existing controls and evidence are already mapped, adding ISO 27001 or SOC 2 builds on the work you have done rather than starting again.
Yes. ISO 13485, IEC 62304 and UK MDR come pre-mapped to the controls you already evidence, and the eQMS gives you SOPs, training records, CAPAs and audits built to ISO 13485. That means your quality system is in place before the certification date, not scrambled together after it.
Compliance that scales
with your growth
See your own control set cross-mapped in days or weeks, not months.