Medical Device & Digital Health Regulatory Compliance
Regulatory readiness and compliance for medical devices and digital health products: quality systems, clinical evidence strategy, risk management, and documentation.
Best for
Device makers, digital therapeutic builders, diagnostics innovators, and labs transitioning prototypes into regulated products.
Outcomes
What you get
- Regulatory strategy and documentation checklist tailored to target markets
- Quality management system (QMS) scaffolding and risk management
- Clinical validation and evidence plan aligned to use-case and claims
- Procurement-facing compliance pack for hospitals and donors
Typical engagement models
- Diagnostic sprint: assessment + roadmap (2–4 weeks)
- Delivery project: execution + handover (6–16+ weeks)
- Fractional advisory: ongoing leadership support
Approach
A practical, stakeholder‑aligned delivery method
This work is designed to reduce execution risk by aligning clinical workflows, implementation realities, and market/procurement constraints—so the solution can scale sustainably.
1) Discovery & constraints mapping
Stakeholder interviews, workflow mapping, current stack review, risk and constraint register.
2) Strategy + architecture decisions
Target operating model, data/interoperability choices, governance, and delivery plan.
3) Implementation & partner coordination
Vendor alignment, milestones, integration planning, change management, and adoption program.
4) Evidence, quality & compliance
Documentation, validation approach, privacy/security basics, and procurement readiness.
5) Scale, monitoring & continuous improvement
MEL metrics, dashboarding, operating cadence, and iteration roadmap.
Deliverables
You’ll receive a clear package
- Scope, timeline, and responsibilities (RACI)
- Roadmap with sequencing and dependencies
- Risk register + mitigation plan
- Success metrics and monitoring plan
- Stakeholder engagement plan
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FAQ
Questions about this service
A scoped discovery phase, stakeholder alignment, a clear delivery plan, documented outputs (roadmap/deliverables), and a practical implementation or scale pathway.
By designing around procurement cycles, interoperability, workforce constraints, low connectivity, and sustainability—while aligning to national priorities and reporting needs.
Current product or program docs, stakeholder list, existing workflows/stack, constraints (budget/timeline), and access to decision‑makers for discovery interviews.
Typically 2–4 weeks for a diagnostic and roadmap; 6–16+ weeks for delivery and scale support depending on scope and complexity.
Yes. I can lead vendor coordination, integration planning, and change management alongside your technical and clinical teams.
Send a brief overview and goals. I’ll respond with clarifying questions and propose a scope, timeline, and deliverables.
Next step
Tell me your context and goals
I’ll respond with clarifying questions and a structured proposal—scope, deliverables, timeline, and success metrics.