From early classification through to post-market compliance and NHS deployment, DPM Digital Health Consultancy supports digital health manufacturers and healthcare organisations on their regulatory journeys.
We combine regulatory expertise with clinical safety and real-world NHS experience,
helping teams meet requirements properly, not just on paper.
DPM provides hands-on regulatory support that provides a clear pathway to commercial software sales through proper compliance.
UK MDR and EU MDR
Software as a Medical Device (SaMD)
Clinical risk management and NHS safety standards
Quality management and post-market obligations
Regulatory pathway and classification
UKCA / CE marking support
Technical and clinical documentation
Whether you’re building or scaling regulated healthtech products, or need clarity on regulatory gaps, we can help.
Engagements can range from end-to-end compliance support – from classification through certification – to targeted advice on specific regulatory requirements. Our focus is always on building sustainable processes that support future product development and long-term regulatory readiness.
If this sounds like what you need, get in touch.
Our regulatory work is led by senior clinicians, Clinical Safety Officers (CSOs), and regulatory specialists with real NHS and healthtech experience.
We understand how regulation, safety, and deployment intersect, and what happens when they don’t line up.
Book a call to discuss your product, risk profile, and what you need.
