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Assuric

All-in-one AI-Powered Platform with Expert Support

Digital health compliance
simplified

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

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Trusted by both digital health companies and healthcare organisations

  • Kanjo
  • Rosenfield
  • VitVio
  • Megi Your Health Assistant
  • Tandem
  • Chequp
  • Rhades
  • Joy
  • ONION AI
  • Heim
  • Think Divergent
  • Theta
  • Healthnix
  • Kanjo
  • Rosenfield
  • VitVio
  • Megi Your Health Assistant
  • Tandem
  • Chequp
  • Rhades
  • Joy
  • ONION AI
  • Heim
  • Think Divergent
  • Theta
  • Healthnix
ASSURIC

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

the problem

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 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

benefits

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

product overview

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 logo

ISO 27001

Information Security Management Systems

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Information Security
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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

Cyber Essentials Certification
NHS Data Security and Protection Toolkit
ISO 27001 Certification

Quality Management System (QMS)

Ensure consistent quality control across your entire product lifecycle, whilst seamlessly meeting regulatory requirements and passing audits

ISO 9001 Quality Management
ISO 13485 Medical Devices

Clinical Safety Management System (CSMS)

Identify clinical hazards, implement safety controls, and maintain compliance - protecting patients and reducing risk

NHS DCB0129 Clinical Safety
ISO 14971 Risk Management
CQC Registration
Features

A suite of indispensable features and tools

Compliance is complex, but our powerful tools simplify it. Discover everything you'll need...

AI-Powered ComplianceAI-Powered Compliance

AI-Powered Compliance

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

Intelligent Document & Policy ManagementIntelligent Document & Policy Management

Intelligent Document & Policy Management

Create, track and update all of your compliance documents automatically. Smart compliant review and approvals ensuring seamless management

Clinical Risk ManagementClinical Risk 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 & DPOFractional CSO & DPO

Fractional CSO & DPO

Qualified experienced Clinical Safety Officers and digital health specialised Data Protection Officers available

Penetration TestingPenetration Testing

Penetration Testing

Identify and remediate vulnerabilities with CREST- accredited security assessments

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Information Security ManagementInformation Security Management

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 ComplianceTraining & Staff Compliance

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 Expert Consultancy & Support

Expert Consultancy & Support

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

Trust CentreTrust Centre

Trust Centre

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

Audit & CertificationAudit & Certification

Audit & Certification

Automate internal audits, streamline external audits and certification processes, and ensure full regulatory compliance

testimonials

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
Heim

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
Tandem

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
VitVio

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
Healthnix

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
DPM

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...

frameworks

All of your compliance requirements in one place

Required frameworks spanning data protection, information security, clinical safety and medical device regulation

Cyber Essentials

Cyber Essentials

Certified baseline of cybersecurity controls for UK based organisations

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ISO 27001

ISO 27001

Global standard for robust information security management systems

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GDPR

GDPR

Mandated data protection and privacy regulation across EU and UK

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NHS DSPT

NHS DSPT

Data security and protection requirements for NHS suppliers and organisations

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NHS DTAC

NHS DTAC

NHS Digital Technology Assessment Criteria, mandated for NHS suppliers

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DCB 0129

DCB 0129

Digital clinical safety standard for manufacturers of digital health solutions.

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DCB 0160

DCB 0160

Clinical risk management for organisations deploying digital health solutions

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HIPAA

HIPAA

US law to protect privacy and security of Protected Health Information (PHI)

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ISO 14971

ISO 14971

Application of risk management for medical devices

Coming soon
ISO 13485

ISO 13485

Quality management system standard for medical devices

Coming soon
IEC-62304.png

IEC 62304

Software lifecycle processes for medical device software

Coming soon
CQC

CQC

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

Coming soon
SOC 2

SOC 2

US-based framework of information security controls by the AICPA

Coming soon
ISO 9001

ISO 9001

Globally recognised quality management system (QMS) standard

Coming soon
ISO 42001

ISO 42001

International standard for AI management system (AIMS)

Coming soon
Custom

Custom

Add your own custom framework or adapt from existing

Coming soon
organiSationS

Built for the needs of
every organisation at any stage

Whether you're a digital health company or a healthcare organisation, big or small

Start-ups

Accelerate your initial deployments, fast-track procurements and avoid compliance debt from day one

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Scale-ups

Keep on top of compliance as you grow, passing audits and securing major contracts with ease

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Enterprise

Increase operational efficiency, maintain oversight, and reduce risk across complex organisations

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GP Practices

Simplified supplier assessments, information governance and clinical risk management for small teams

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Hospital Trusts

Streamline supplier due diligence, maintain oversight, and deliver safe and secure deployments

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ICBs

Coordinate system-wide risk assessments, maintain visibility of deployments and reduce duplication

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integrations

Seamless integrations for a smarter workflow

Seamlessly integrate your existing workflows and tools, to automate everything from security monitoring to incident management.

Blog

Latest articles from the team

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Make 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.

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