Medical device compliance
Supporting safe, compliant digital health research under UK MDR 2002.
Developing digital tools that influence health or care pathways often brings them into the scope of the UK Medical Devices Regulations (MDR 2002). We help research teams navigate this landscape by providing practical support, clear guidance, and the technical documentation required for Software as a Medical Device (SaMD).
Our team ensure regulatory compliance with standards such IEC 62304, ISO 14971, UKMDR requirements and MHRA guidelines. Whether a project is already classified or requires early-stage advice, we help determine the appropriate regulatory pathway and ensure all required evidence and controls are in place.
What we do
- Develop SaMD products that support diagnosis, monitoring, treatment, or clinical decision support
- Ensure regulatory compliance with standards such IEC 62304, ISO 14971, UKMDR requirements and MHRA guidelines
- Manage our processes through a QMS aligned to ISO 13485
- Integrate your clinical expertise to ensure that product requirements, safety profiles, and user workflows align with real-world healthcare needs
- Maintain quality and cybersecurity, embedding risk management, validation, and secure development practices throughout the product lifecycle
Our role in the SaMD compliance process
Outcomes
- Regulatory-ready SaMD products that meet international standards and can be cleared or approved for use in the UK
- Safe, effective, and clinically relevant software that improves patient outcomes and supports healthcare decision-making
- Efficient and traceable development workflows that reduce risk, accelerate compliance, and support long-term scalability.
- High stakeholder confidence, built through transparent documentation, robust risk controls, and consistent quality management.
In action
The REMORA study involved developing a digital symptom-tracking tool for people with rheumatoid arthritis. As REMORA fell within the scope of UK MDR 2002, our team led the full SaMD compliance process. This included producing DCB0129 documentation, managing risk assessments, completing DPIAs, and integrating regulatory requirements into the development workflow. Our involvement ensured the system was safe, robust, and suitable for clinical evaluation, enabling the study team to progress confidently through regulatory and governance approvals.
