MedTech
For medical device and MedTech product organisations that must align engineering, evidence and documentation early — before late-stage gaps become expensive.
Who this is for
Manufacturers, product owners and RA/QA leads working on devices, device–software combinations or MedTech platforms where intended use, risk controls and documentation must stay coherent across engineering and regulatory workstreams.
Typical problems
- Late documentation gaps that surface only near submission or audit
- Unclear intended use shared inconsistently across product, clinical and RA teams
- Software/device boundary questions — including a reasoned SaMD qualification view
- Dual EU and US expectations without a single narrative
- Engineering delivery that is strong technically but weak on traceability
Example scenarios
- Hardware + software system — aligning firmware / application claims with risk management and technical-file structure
- Ophthalmology or specialty devices — plan and inspection-facing documentation for a US pathway (see anonymised selected work)
- Software-heavy MedTech — IEC 62304-oriented lifecycle and SaMD qualification view
- Dual-market launch planning — naming what is shared scientifically vs what must stay region-specific
How we approach MedTech programmes
We connect product engineering, evidence needs and regulatory documentation early — using the same stages as our overall method (How we work):
- Discover — goals, constraints, intended use drafts, evidence and documentation gaps
- Frame — scope, exclusions, owners; clarify device vs software boundaries where relevant
- Build — engineering, methodology and/or documentation increments tied to risk and intended use
- Harden — review readiness, traceability, gap notes for QMS and submissions
- Hand over — artefacts and next steps toward conformity and submissions
What we typically deliver
- Structured support for medical/life-sciences software in device contexts
- SaMD qualification view and design-phase discipline when intended use points to device rules
- Device documentation readiness and gap structuring
- Regulatory writing and interaction preparation for the applicable pathways
- Explicit handling of EU- and US-oriented expectations where both matter
Relevant expertise
Medical software · SaMD support · Device readiness · Regulatory support · EU & US support
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.