The Office for Translational Research supports University of Cambridge researchers and clinical teams from associated hospitals developing medical devices, digital health technologies and software that may require a regulatory pathway.
Medical device regulation is complex. We provide practical support at early, mid and pre-submission stages of development, helping teams understand regulatory requirements, structure technical documentation, and prepare for the next step in translation.
Our support is designed to reduce uncertainty, improve readiness, and strengthen documentation and governance as projects move towards clinical evaluation, adoption or commercial development.
What we can offer
OTR can support projects with proportionate, stage-appropriate regulatory input, including:
- early-stage regulatory scoping for medical devices and health software
- advice on intended purpose, claims, users and regulatory positioning
- support with device classification and route planning
- technical documentation structuring and evidence mapping
- guidance on quality and document control processes
- support with risk, usability, software lifecycle and clinical evidence documentation
- regulatory input into translational funding applications and development plans
- coordination with relevant internal and external experts, including governance and clinical partners
- Bespoke training courses and workshops
Tools and infrastructure
We can also provide access to, or support with, selected tools and systems that help teams manage regulatory documentation more effectively.
| Cognidox eQMS | RegMetrics | Templates and Workflows |
|---|---|---|
|
Controlled document management, review workflows, approvals and traceability for technical documentation. |
Support for device classification, regulatory evidence mapping and structured route planning. |
Practical documentation templates and structured approaches for technical file development. |
When to engage with the OTR
We encourage teams to engage early, particularly where a project may involve:
- software influencing clinical decision-making
- AI or algorithm-based tools intended for clinical use
- connected or standalone medical devices
- preparation for translational funding, clinical investigation or future conformity assessment
Early engagement helps clarify scope, identify evidence gaps, and establish a proportionate regulatory plan before significant development effort is committed.
How we work
Our role is to support and coordinate regulatory readiness. Depending on the project, we can help draft, structure or review documentation, support evidence collation, and guide teams towards the appropriate internal and external pathways.
Regulatory ownership and formal sponsor or manufacturer responsibilities remain with the appropriate project leads and organisations.