Take your medical device software to market, faster
If your software diagnoses, monitors, treats or prevents a medical condition, it is likely regulated as a medical device. Assuric helps healthtech and AI companies determine whether they are in scope and manage everything from ISO 13485 and ISO 14971 to IEC 62304, clinical evaluation and MHRA registration, all in one platform.
Your route to market
Classification and intended purpose
The wording that drives everything
ISO 13485 quality management system
Controlled documents, e-signatures
ISO 14971 and IEC 62304
Risk and software lifecycle
Clinical evaluation
Evidence for your claims
MHRA registration
UKCA marked and listed
Risk rises with class, and so does the work to reach market. Your intended purpose decides where you sit.
Lowest risk. Self-certification and MHRA registration, the fastest route to market.
Most SaMD starts hereModerate risk. An approved body assesses your device from here upwards.
Higher risk. Deeper approved body scrutiny of your technical documentation.
Highest risk. The most demanding conformity assessment before market.
Tell us what your product does and we will help you work out whether you are in scope, and what class you are likely to be.
We are trusted by
We can support you across the whole route to market:
Get clear on whether you are a medical device, and whether you are Class I, IIa, IIb or III. Your intended purpose drives the whole thing, and the exact wording matters, so getting it right early can save you a great deal of time and cost.
Classification
Intended purpose defined
The wording that drives everything
Medical device?
Assessed against UK MDR
Classification
Rule-by-rule assessment
The fastest route to market for lower-risk software. We help you prepare your technical file, clinical evaluation and declaration of conformity, and register with the MHRA.
Technical file
Class IPrepared with our team
Key documents
Build the quality management system notified bodies and buyers expect, with controlled documents and e-signatures. See our ISO 13485 page for the detail.
Quality management system
Documents
Records
Controlled documents with e-signatures and audit trails.
Manage your ISO 14971 device risk management and your IEC 62304 software development traceability in one place, linked to the rest of your quality system.
Linked by design
Your quality system
One place, fully traceable
ISO 14971 risk file
LinkedIEC 62304 lifecycle
LinkedTechnical documentation
LinkedIf your product uses AI, we fold AI-specific policies into your quality system so you meet expectations without a separate regime. Practical, not painful.
Generate Policy
Suggested
AI Model Management Policy
Folded into your quality system
Performance Monitoring SOP
Folded into your quality system
Meet the clinical risk management the NHS expects from manufacturers, and reuse that work across your medical device documentation. See our DCB0129 page.
Hazard log
Clinical safety at a glance
Work with our team for ad-hoc advice or hands-on help, including acting as your Clinical Safety Officer where you need one. You get people who have done this before, not just software.
Ask an expert
You
Do we need a Clinical Safety Officer before our NHS pilot?
Assuric
Yes, and we can act as yours. We will have your DCB0129 documentation ready for the pilot too.
Compliance is complex, but our AI tools simplify it. Discover features to stay ahead of regulations.
Kelly Klifa
CEO at Heim
Assuric has been transformative for Heim as we looked to achieve DCB0129 and DTAC compliance. The platform is easy to use, and the AI tools and automated reminders make previously dreaded compliance tasks a breeze. Paul and Matt supported us every step of the way.
Katie Baker
Director UK & Ireland at Tandem
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!
Maks Kozarzewski
COO at VitVio
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!
Maja Mazur
CEO at Healthnix
Assuric has been such a blessing in getting our DTAC and GDPR compliance done - completing all the documentation and deciding what needs to be done whilst running the business is very hard, but the team really helped us through that. The platform is easy to use, helps keep track of things and it even allows us to coordinate all the team training easily. Highly recommend them!
Dean Mawson
Clinical Director at DPM
Assuric streamlines the process of achieving and maintaining compliance with DCB0129 standards for digital health technologies. The user-friendly interface simplifies collaboration across multidisciplinary teams, while the built-in templates and workflows save significant time and effort during compliance projects. Assuric’s ability to centralise documentation and provide real-time visibility into project progress is particularly beneficial for Clinical Safety Officers and digital project teams, enhancing both efficiency and assurance.
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