Why Regulatory Strategy Should Precede Architecture, Not Follow It
The single most expensive sequencing mistake in health-tech is building first and asking the regulatory question second.
CAD CARE INSIGHTS · REGULATORY INTELLIGENCE
The single most expensive sequencing mistake in health-tech is building first and asking the regulatory question second.
SaMD classification changes what evidence, documentation and quality-system rigour a product needs — and that classification depends on intended use claims decided during product design, not after it.
Retrofitting clinical evaluation evidence onto an already-built product is possible but slower and more expensive than designing the evidence plan alongside the architecture.
A short regulatory scoping conversation at the start of a build is inexpensive. The same conversation after a product is in market can mean re-architecting core claims.
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