Architecture Qualification
Stress-test your architecture against regulatory, clinical, and commercial realities, and surface the changes you would rather find now than at FDA review.
Overview
Architectural decisions made in stealth mode often look obvious until a regulator, customer, or auditor pushes on them. The model is too big to run at the edge where the customer needs it. The deployment model triggers data residency rules the founders had not considered. The integration assumption requires standards none of the target customers actually support.
We run a structured stress test before these collisions happen, and surface the changes that would be cheaper now than later.
Our Process
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1
Architecture documentation
Capture current state across model, deployment, data, and integration.
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2
Regulatory stress test
Each component against likely regulatory requirements.
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3
Clinical workflow stress test
Each component against target customer workflow constraints.
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4
Commercial stress test
Each component against procurement and IT review requirements.
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5
Change proposal memo
Recommended changes with cost / benefit / timing.
Frequently Asked Questions
Is this redundant with a software architecture review?
No, we test the architecture against external constraints, not internal engineering trade-offs.
How early should we do this?
Before the second major engineering investment. Earlier is cheaper.
Do you recommend specific technologies?
We recommend constraints; technology selection is your engineering call.
Can the report be shared with investors?
Yes, investors often value this independent stress test.
Find the architecture problems now, not at FDA review.
Send us your current architecture documentation. We will return a stress-test report within four weeks.
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