Digital health regulatory compliance.

Specialists in
DBC0129 & DCB0160

At DPM Digital Health we specialise in providing comprehensive services tailored to meet the requirements of DCB0129 and DCB0160 standards.

We understand the critical importance of adhering to DCB0129 and DCB0160 standards throughout the entire lifecycle of Health IT Systems. 

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 conception to decommissioning.

Our tailored approach and commitment to excellence allows our clients to navigate the complexities of healthcare regulations DCB0129 and DCB0160 confidently while prioritising patient safety and quality of care.

Team work, collaboration, subject matter expertise.

Team work is an essential part of any organisation which is the foundation for DPM Digital Health.

We have the expertise to support and maintain regulatory compliance focusing on Clinical Risk and Quality Management. All our team members have previous or existing NHS experience working on digital health projects at a senior level. 

Of those team members several are members of the Faculty of Clinical Informatics and advise and guide legislation at a national level. We have built and maintain healthy relationships with other professionals utilising the best expertise in the sector to implement sustainable regulatory compliance.

Safety in numbers.

On your plate quick win into the weeds, but the closest elephant is the most dangerous, and rock Star/Ninja, or circle back bake it in.

Great plan! Let me diarize this.

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Our services.

Clinical Risk Management

  • DCB0129/DCB0160 compliance
  • Clinical Risk Management Plans
  • Hazard Logs
  • Clinical Safety Case Reports
  • Clinical Risk Management System implementation and integration

Quality Management Systems

  • ISO 13485 compliance and maintenance
  • ISO13485 gap analysis and internal audit
  • External audit support
  • Integration with existing organisational processes and legislation

UK Medical Device Regulation

  •  
  • UK & EU MDR compliance (UKCA & CE marking)
  • Technical Files
  • Clinical Evaluation Plans and Reports
  • Post Market Surveillance and Vigilance
  • Harmonised Standards

Information/Cyber Security

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

Digital Technology Assessment Criteria (DTAC)

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

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