Services.

Our digital health
expertise

We are here to support you and your team every step of the way, whether it is providing hands on DCB0129/0160 compliance, training your team on clinical risk management or providing subject matter expertise to manage your entire regulatory compliance journey. 

We get it because we have been living and breathing compliance for over 25 years in the Digital Health sector.

At DPM Digital Health we support Health Organisations and Digital Health manufacturers with their regulatory compliance needs. 

By utilising subject matter expertise within the healthcare sector we are able to give back our own experiences to enhance the knowledge and skill sets of those organisations that are trying to make a difference. 

It is our goal to make sure that Digital Health technologies are designed, developed, deployed and implemented in a safe and effective manner enabling the Healthcare Community to deliver care management safely.

Our pedigree speaks for itself working with the NHS and Digital Health industry on numerous Digital Health projects, representing the Clinical Safety community at conferences and on Healthcare forums, publishing guidance documentation in support of the Clinical Risk Management process and having many years’ experience working in frontline clinical areas.

We provide comprehensive support for DCB0129/0160 compliance, clinical risk management training, and regulatory expertise. With over 25 years of experience in Digital Health, we ensure safe and effective implementation of healthcare technologies.

Our services include

Hands-on DCB0129/0160 compliance assistance

Clinical risk management training

End-to-end regulatory compliance guidance

Drawing from our extensive frontline clinical experience, we’ve worked with the NHS and Digital Health industry on numerous projects. We represent the Clinical Safety community at conferences and healthcare forums and publish guidance documentation to support Clinical Risk Management processes.

 
Our goal is to enhance healthcare delivery by ensuring Digital Health technologies are designed, developed, deployed, and implemented safely and effectively.

Clinical Safety

  • CSO service including mentorship
  • DCB0129 compliance
  • DCB0160 compliance
  • Clinical Risk Management governance 

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 
  • AI Management System
  • Assurance of Machine Learning for Autonomous Systems (AMLAS)

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