I work as a fractional system architect for MedTech companies — taking responsibility for architecture decisions, technology selection, and system design from early requirements through clinical validation. Typically 0.3–0.6 FTE, embedded with your team, for 3–12 months depending on the engagement stage.
What this looks like in practice
For early-stage companies (pre-Series A):
If you are approaching investor due diligence or starting a CE-mark programme, the architecture and regulatory foundations matter now — not after funding. I can set up your system architecture, define the technology stack, and establish the IEC 62304 and ISO 13485 structural requirements before the review. Most founders without a clinical device background don’t know what the reviewers will look for. I do — I have audited QMS for a Fortune-100 medical device company.
For scale-ups (Series A and beyond):
If you have an ongoing CE-mark process and specific technical gaps in real-time, imaging, or interventional subsystems, I can provide senior architect bandwidth on those gaps without the overhead of a full-time hire. Typical commitment: 24–32 hours per week, 6–12 months.
Domain experience
Architecture for clinical imaging and interventional cardiology systems. Real-time multi-modal data integration — video, ultrasound, positional. VR-based pre-operative planning and risk assessment. Validated systems in clinical settings with practitioners.
Credentials
- ISO 13485 internal auditor — full QMS audit cycle (3–4 audits/year, Fortune-100 medical device company)
- IEC 62304 medical device software lifecycle familiarity
- 15 granted patents (human-computer interaction, clinical imaging interfaces, mixed reality systems)
- 6 peer-reviewed publications (clinical informatics, medical imaging)
Virtual Frontier 