Digital Health
For digital health builders whose products sit near or within medical-software expectations — where intended use, qualification and documentation discipline matter as much as shipping features.
Who this is for
Founders, product and engineering leads, and RA partners building clinical, care-pathway or operational software that should be assessed and, where indicated, built as medical device / SaMD software from the start.
Typical problems
- Intended-use ambiguity between product marketing and engineering reality
- Fast engineering without documentation or risk-control discipline
- SaMD or device qualification left until late in the roadmap
- Teams unsure how EU and US software expectations differ
- Generic IT partners who cannot speak regulated-context language
Example scenarios
- Intended-use workshop — separating wellness / admin claims from medical purpose before marketing hardens
- Regulated engineering — delivery with IEC 62304 / ISO 14971-oriented practices and traceability inputs
- AI-enabled clinical tooling — documentation themes for EU AI Act alongside MDR/IVDR and FDA AI/ML where relevant
- Late SaMD surprise — qualification view plus remediation so architecture, logs and documentation catch up
How we approach digital health
We treat intended use, architecture and documentation as one programme — not as an afterthought. Method stages (How we work):
- Discover — product claims, users, data flows, known regulatory pressure points
- Frame — reasoned SaMD / device-software view; scope of engineering vs documentation support
- Build — software delivery with quality-relevant practices; design as regulated software when qualification is a reasonable possibility
- Harden — traceability, readiness notes, alignment with RA writing if needed
- Hand over — artefacts, remaining filing steps and open questions
What we typically deliver
- Medical and life-sciences software engineering support
- SaMD qualification view and design-phase discipline when intended use points to device rules
- Documentation inputs suitable for later quality or regulatory review
- Coordination with regulatory strategy and device readiness workstreams
Relevant expertise
Medical software · SaMD support · Regulatory support · Selected work · Trust
For role boundaries (regulator, notified body, certification, outcomes), see Trust.
Ready to discuss a programme?
Tell us about your organisation and the type of support you need.