Situation
First-time founders at a seed-stage diagnostics startup had a technically innovative platform for liquid biopsy but no regulatory architecture.

What We Did
We developed a Regulatory Strategy, mapping viable U.S. pathways and evidence burdens, then converging on a near-term Class I implementation to enable rapid, lower-risk entry. In parallel, we defined a staged claims and evidence framework that can extend to a future PMA-class indication as data and product mature.

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Benefit
The founders gained a coherent product and regulatory roadmap that linked intended use, claims evolution, and evidence generation and used it to secure a $250K+ non-dilutive funding. It aligned product strategy with regulatory milestones and equipped them to present a credible, risk-managed plan to investors.

Situation
A MedTech imaging company had defined a 510(k) pathway for an adjunct AI SaMD but had to tighten and de-scope claims to remain in that route. Critical questions were still open around what FDA would accept for clinical validation, truthing methodology, PCCP, and human factors before committing to full-scale studies and dossier assembly.

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What We Did
We designed a coherent Pre-Submission strategy, built a structured FDA question set across validation, truthing, PCCP, and HF, and helped draft the underlying protocols to obtain clear FDA feedback. 

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Benefit
The team emerged with a clear, regulator-aligned plan: 100% of their critical questions were answered, the validation and PCCP approaches were cemented, and they moved into dossier development with confidence culminating in 510(k) clearance for the SaMD.

Situation
A mid-size manufacturer/distributor of medical convenience kits wanted ISO 13485 to match customer expectations and win bigger contracts, but was running on a home-grown QMS: inconsistent SOPs, weak lot/production traceability, limited 13485 literacy.

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What We Did
We architected and implemented a full ISO 13485-compliant QMS on their existing paper/SharePoint backbone, covering all necessary modules. Then we used it to close legacy gaps and walk the organization through Stage 1 and Stage 2 certification audits.

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Benefit
They achieved ISO 13485 certification on the first attempt with zero Stage 2 findings, gained real visibility into quality and traceability, and immediately became eligible for customers and opportunities.