Services.

Practical clinical safety, regulation, and governance training and support delivered by a team that’s been there.

Regulatory compliance specialists for healthtech.

DPM Digital Health Consultancy supports healthcare organisations and healthtech developers to design, deploy, and scale digital technologies safely, compliantly, and with confidence.

Modular, flexible support
when you need it.

From early design and assurance through deployment, operation, and safe decommissioning, organisations work with us to:

  • Build internal capability
  • Access experienced clinical safety leadership
  • Meet regulatory requirements that stand up to scrutiny
  • Govern AI and digital tools responsibly

We don’t do “box-ticking” compliance.

Everything we deliver is grounded in real NHS and frontline experience proportionate, defensible governance, and delivers practical implementation that teams can sustain.

Whether you need training, additional capacity, or end-to-end regulatory support, we help you move forward safely.

Our core services.

DPM Digital Health Consultancy works across six core service areas, all focused on the goal of ensuring digital health technologies are safe, compliant, and fit for real-world care. 

Training and Education.

Help to build internal capability that lasts.

Practical, hands-on regulatory and clinical safety training for healthcare and digital health teams – either as individuals or as a group.

Best for healthcare organisations, startups, scale-ups, research teams, and digital leaders building internal compliance capability.

Includes:

  • Clinical Safety Officer (CSO) training
  • DCB0129 / DCB0160 compliance
  • EU MDR preparation
  • ISO standards training
  • AI governance and risk management

Why organisations choose this:

  • Closes the gap between theory and real-world implementation
  • Focuses on scalable processes, not rote learning
  • Reduces long-term dependency on external consultants

CSO as a Service.

Experienced clinical safety leadership, when and where you need it.

Access senior, independent Clinical Safety Officers without the cost or delay of permanent recruitment.

Best for organisations without an internal CSO, or with overstretched or junior CSO capacity.

Includes:

  • Named CSO support for digital health programmes
  • DCB0129 / DCB0160 leadership and safety case oversight
  • Support for AI tools, EPRs, digital workflows, and medical software
  • Capacity to clear backlogs or support major deployments

Why organisations choose this:

  • Immediate access to seasoned CSO expertise
  • Independent authority that won’t buckle under pressure
  • Flexible capacity that scales with demand
  • Knowledge transfer to internal teams

CSO Mentoring.

Develop confident, resilient Clinical Safety Officers.

The UK’s only structured CSO mentoring programme, designed to support CSOs navigating complex, high-pressure roles.

Best for healthcare organisations and digital teams developing junior or newly appointed CSOs.

Includes:

  • Structured mentoring for individual CSOs or teams
  • Support handling organisational pressure and scope creep
  • Practical guidance grounded in real-world experience
  • Consistent standards across teams

Why organisations choose this:

  • Builds confidence and judgement, as well as knowledge
  • Reduces burnout and improves retention
  • Moves teams from reactive firefighting to proactive risk management

Medical Device Regulation (MDR).

Defensible compliance for regulated healthtech software and medical devices.

End-to-end MDR support for organisations developing or deploying regulated digital health technologies.

Best for healthtech startups, scale-ups, and healthcare organisations developing regulated software.

Includes:

  • Classification and regulatory strategy
  • UKCA, CE, and international compliance
  • Clinical safety and risk management alignment
  • Support for healthcare organisations acting as manufacturers

Why organisations choose this:

  • Clear navigation through complex regulatory requirements
  • Phased, realistic investment planning
  • Compliance that stands up to buyer, auditor, and regulator scrutiny
  • Dual clinical and manufacturer perspective.

ISO Regulation Compliance.

Quality systems that strengthen organisations – not just pass audits.

Implementation and assurance of ISO standards that support governance, safety, and sustainable growth.

Best for healthcare organisations and healthtech developers needing robust, scalable quality systems.

Includes:

  • ISO 13485 (medical devices)
  • ISO 27001 (information security)
  • ISO 42001 (AI management systems)
  • Integrated quality and risk management systems

Why organisations choose this:

  • Avoids costly rework and re-audits
  • Uses standards strategically, not superficially
  • Builds operational maturity and market credibility
  • Future-proofs against emerging requirements

AI Governance and Risk Management.

Turn the potential of AI in health and care into safely governed capability.

Healthcare-specific AI governance and risk management, grounded in patient safety.

Best for all healthcare organisations and digital health developers using or exploring AI.

Includes:

  • ISO 42001, EU AI Act, and AMLAS frameworks
  • Practical AI governance models
  • Risk management for real-world AI use
  • Training that supports safe adoption.

Why organisations choose this:

  • Moves teams from uncertainty to clarity
  • Avoids generic, non-healthcare AI guidance
  • Enables early, proportionate governance
  • Supports innovation without compromising safety.

Not sure where to start?

Many organisations come to us unsure which standards apply, where accountability sits, or how to prioritise next steps.

We can help. Talk to us to:

  • Understand your regulatory position
  • Identify gaps and risks
  • Agree a proportionate, defensible plan

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Our team.

Our team brings senior NHS, clinical, and regulatory experience across provider and supplier settings. They deliver training, CSO services, provide mentoring, and are on hand to help, whenever you need it.

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