
Digital health compliancesimplified
Assuric enables digital health companies and healthcare organisations to exceed compliance requirements, and deploy technology with speed and confidence.



Trusted by both digital health companies and healthcare organisations
How Assuric works in 3 simple steps
STEP 1
Comprehensive onboarding
We meet you wherever you are with compliance, perform a thorough gap analysis, and upload any existing documentation and evidence
STEP 2
Intuitive automated compliance
Easily fill any gaps, automate tasks, track compliance, and receive proactive alerts - ensuring requirements are met in record time
STEP 3
Audit, certification and maintenance
Sail through audits, achieve all of the necessary certifications, and enjoy painless maintenance
Compliance challenges
Navigating digital health compliance is daunting - multiple frameworks, evolving strict regulations, and slow manual processes can stall innovation and drain resources. Here are a few of the biggest challenges...
Multiple Framework Overload
Digital health companies often struggle to meet requirements across GDPR, NHS DTAC, DSPT, DCB0129, ISO standards and more.
Time-Consuming Manual Processes
Endless spreadsheets, scattered documentation, and repetitive tasks slow you down.
Complex Clinical & Security Risks
Overlooking clinical hazards or cybersecurity gaps can compromise patient safety and erode trust.
High Costs & Resource Constraints
Hiring or training in-house teams or outsourcing everything can be both slow and expensive, especially for SMEs.
Rapidly Evolving Regulations
Keeping pace with frequent changes in digital health requirements is challenging and creates compliance blind spots.
Upcoming Audit Anxiety
Without centralised evidence and automated process, preparing for certifications or external reviews is stressful and time-consuming.
Address these pain points head-on…
We'll help you safeguard patients, gain trust and scale faster
Why use Assuric ?
Effortless compliance - from onboarding through to certification and maintenance, so you can redirect resources to where they are needed most
Time & cost saving
Eliminate painful spreadsheets and manual processes, while avoiding expensive outsourcing or unnecessary hires.
Reduce risk
Maintain oversight, implement effective controls, and ultimately reduce the risk of data breaches and patient safety incidents.
Accelerate deployment
Slash timelines from development to certification to deployment - accelerating your path to market and scale.
Specialised for digital health
Designed by clinicians, and clinical safety and data security experts, always with patients and healthcare in mind.
Goodbye spreadsheets,
hello automation
Your All-in-one AI-powered Compliance Solution
A single source of truth with everything you need for digital health compliance in one place, combined with expert hands-on support at every step.

ISO 27001
Information Security Management Systems
The only all-in-one automated...
Information Security Management System (ISMS)
Safeguard sensitive data through industry-leading compliance, using automated security protocols and continuous monitoring



Quality Management System (QMS)
Ensure consistent quality control across your entire product lifecycle, whilst seamlessly meeting regulatory requirements and passing audits


Clinical Safety Management System (CSMS)
Identify clinical hazards, implement safety controls, and maintain compliance - protecting patients and reducing risk



A suite of indispensable features and tools
Compliance is complex, but our powerful tools simplify it. Discover everything you'll need...


AI-Powered Compliance
A host of AI features including policy generation, evidence collection, change reporting, gap analyses, and more...


Intelligent Document & Policy Management
Create, track and update all of your compliance documents automatically. Smart, compliant review and approvals ensuring seamless management


Clinical Risk Management
End-to-end clinical safety case management with specialised hazard logs, tracked control implementation, automated report writing, and integrated incident management and post-deployment monitoring
Clinical Safety Overview

Fractional CSO & DPO
Qualified, experienced Clinical Safety Officers and digital health specialised Data Protection Officers available


Penetration Testing
Identify and remediate vulnerabilities with CREST-accredited security assessments
Book a test

Information Security Management
Centralise and automate security control implementation and tracking, asset and supplier management, and specialised security risk management and treatment
Infosec and data protection overview

Training & Staff Compliance
All the necessary staff training you’ll need (both basic and specialist), combined with automated tracking and reminders to ensure compliance


Expert Consultancy & Support
Rapid expert guidance and support as standard, or opt for a fully managed white-glove service with dedicated consultancy


Trust Centre
Showcase your compliance position and evidence, build trust with customers and stakeholders, and accelerate your deployment


Audit & Certification
Automate internal audits, streamline external audits and certification processes, and ensure full regulatory compliance
What our customers say
Don’t just take our word for it - discover how we've helped real companies deploy real products into healthcare
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.
Ready to accelerate your product deployment?
Talk to us to find out how...
All of your compliance requirements in one place
Required frameworks spanning data protection, information security, clinical safety and medical device regulation

ISO 14971
Application of risk management for medical devices

ISO 13485
Quality management system standard for medical devices

IEC 62304
Software lifecycle processes for medical device software

CQC
Regulatory standards for care quality in UK health and social care services

SOC 2
US-based framework of information security controls by the AICPA

ISO 9001
Globally recognised quality management system (QMS) standard

ISO 42001
International standard for AI management system (AIMS)
Custom
Add your own custom framework or adapt from existing
Built for the needs of
every organisation at any stage
Whether you're a digital health company or a healthcare organisation, big or small

















Seamless integrations for a smarter workflow
Seamlessly integrate your existing workflows and tools, to automate everything from security monitoring to incident management.
Latest articles from the team


Data Protection Essentials for Health Tech Innovators
A practical guide to Data Protection compliance for UK health tech startups - simplify data protection, and scale with confidence.
Cordi Mahony•Nov 19, 2025
Data Protection Essentials for Health Tech InnovatorsMake your life easier
and talk to us to simplify compliance
Goodbye manual processes, hello automation. Let Assuric manage compliance and security, so you can focus on growth.









