MedTech

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 when SaMD may apply)
• Dual EU and US expectations without a single narrative
• Engineering delivery that is strong technically but weak on traceability

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):

1. Discover — goals, constraints, intended use drafts, evidence and documentation gaps
2. Frame — scope, exclusions, owners; clarify device vs software boundaries where relevant
3. Build — engineering, methodology and/or documentation increments tied to risk and intended use
4. Harden — review readiness, traceability, gap notes for client-owned QMS and submissions
5. Hand over — client-owned next steps; we do not certify or clear products

What we typically deliver

• Structured support for medical/life-sciences software in device contexts
• SaMD-oriented planning support when qualification may apply (assessed per product)
• Device documentation readiness and gap structuring — not certificates
• Regulatory writing and interaction preparation for client-owned pathways
• Explicit handling of EU- and US-oriented expectations where both matter

Boundaries

• We are not a notified body, certification body, regulator or clinic
• We do not issue CE certificates or guarantee clearance, approval or conformity outcomes
• Public contact channels are not for PHI or confidential regulatory packs

Relevant expertise

Medical software · SaMD support · Device readiness · Regulatory support · EU & US support