Digital Health

Who this is for

Founders, product and engineering leads, and RA partners building clinical, care-pathway or operational software that may later face device or SaMD questions — or already does.

Typical problems

• Intended-use ambiguity between product marketing and engineering reality
• Fast engineering without documentation or risk-control discipline
• SaMD or device questions arising late in the roadmap
• Teams unsure how EU and US software expectations differ
• Generic IT partners who cannot speak regulated-context language

How we approach digital health

We treat intended use, architecture and documentation as one programme — not as an afterthought. Method stages (How we work):

1. Discover — product claims, users, data flows, known regulatory pressure points
2. Frame — whether SaMD/device pathways may apply; scope of engineering vs documentation support
3. Build — software delivery support with quality-relevant practices and documentation inputs
4. Harden — traceability, readiness notes, alignment with RA writing if needed
5. Hand over — client owns qualification assessments and agency interactions

What we typically deliver

• Medical and life-sciences software engineering support
• SaMD-oriented planning when qualification may apply (per product; we do not grant clearance)
• Documentation inputs suitable for later quality or regulatory review
• Coordination with regulatory strategy and device readiness workstreams

Boundaries

• We do not declare a product is SaMD without client-owned assessment
• We do not present software as cleared or approved without evidence owned by the client
• No clinical care, diagnosis, or PHI via the public contact form

Relevant expertise

Medical software · SaMD support · Regulatory support · Trust