Delivering regulatory compliance
to the digital health community.

Specialists in DCB0129 & DCB0160 and beyond...

At DPM Digital Health we specialise in providing comprehensive services tailored to meet the requirements of the NHS safety standards, DCB0129 Clinical Risk Management: its Application in the Manufacture of Health IT Systems and DCB0160 Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems. 

We understand the critical importance of adhering to DCB0129 and DCB0160 standards throughout the entire lifecycle of digital health technologies. 

With over 75 years of collective experience within the healthcare sector...

…our team is dedicated to ensuring compliance and effectiveness in the application of Clinical Risk Management processes at every stage, from scope definition to decommissioning of a digital health system.

Our tailored approach and commitment to excellence

allows our clients to navigate the complexities of the standards DCB0129 and DCB0160 confidently while prioritising patient safety and quality of care.

Clinical Safety

  • CSO service including mentorship
  • DCB0129/DCB0160 Audit
  • DCB0129/DCB0160 Compliance
  • Clinical Risk Management governance 

Digital Technology Assessment Criteria (DTAC)

Supported services for each component:

  • Clinical Safety
  • Data Protection 
  • Technical Security
  • Interoperability
  • Usability and Accessibility 

CPD certified training

  • Clinical Risk Management training
  • Clinical Risk Management awareness 
  • CSO Mentorship programme

Regulatory Services

  • Medical Device Regulation (UKCA, CE, FDA)
  • ISO13485 Quality Management System
  • ISO 14971 Risk Management for Medical Device 
  • ISO 42001 AI Management System
  • Assurance of Machine Learning for Autonomous Systems

Information/Cyber Security

  • Data Security & Protection Toolkit (DSPT)
  • Data Protection Impact Assessment (DPIA)
  • Cyber Essentials/Cyber Essentials Plus
  • Data Protection Officer (DPO)
  • ISO27001 compliance, internal and external audit

Team work, collaboration,
subject matter expertise
at your fingertips.

Collaborative Excellence
at DPM Digital Health

Teamwork: Our Foundation
At DPM Digital Health, collaboration is our cornerstone.
We leverage collective expertise to drive success in digital healthcare solutions.

Regulatory Compliance Specialists
Our focus: Clinical Risk and Quality Management.
We ensure your digital health projects meet and exceed regulatory standards.

NHS-Experienced Professionals
Our team brings senior-level NHS experience to every project, guaranteeing practical, real-world insights.

Proven Track Record
Our successes speak volumes.
We forge lasting partnerships through our unwavering commitment to compliance excellence.

Industry Leadership
Several team members are British Computer Society (BCS) affiliates, actively shaping national legislation.

Strategic Partnerships
We cultivate robust relationships across the sector, harnessing top-tier expertise for sustainable regulatory compliance.

Tailored Solutions
Our collaborative approach ensures customised, effective compliance strategies for your unique digital health challenges.

Regulatory Compliance Services.

We support you every step of the way with all aspects of DTAC compliance, making sure you have a comprehensive portfolio of documents that provides your evidence base.

Upcoming events.

Trusted partners.

Get in touch.

We’d love to hear from you.

Simply fill out the form and we’ll get back to you as soon as we can. Alternatively, give us a call on 07840 049772 or email dean.mawson@dpmdigitalhealth.co.uk

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