Who it's for
Founders deciding what they can claim, teams whose product has drifted toward a device claim, and groups preparing for an FDA Pre-Submission meeting. We work alongside your regulatory counsel or consultant; our role is the engineering and evidence side of the decision.
What's included
- Intended use and claims analysis — what the product does, for whom, and which claims cross the device line.
- Classification and pathway — device versus non-device, risk class, and the realistic pathway: 510(k), De Novo, enforcement discretion, or the clinical decision support exemption.
- Design controls plan — IEC 62304 software lifecycle, ISO 14971 risk management, and usability engineering, right-sized to the classification.
- Documentation trail — what must exist, in what form, and how the engineering process will produce it without slowing down.
- Architecture implications — modular boundaries so regulated and unregulated functions can evolve separately.
- Evidence plan — the verification, analytical, and clinical validation the claims will require.
- Pre-Submission preparation — the questions worth asking FDA and the materials to support them.
How it runs
- Product and claims reviewWalk through the product, roadmap, and marketing claims with leadership.
- Position paperClassification, pathway, and the reasoning, in a form counsel and investors can review.
- PlanDesign controls, documentation, architecture, and evidence plan with effort estimates.
- ReadoutLeadership session and, if useful, a joint session with your regulatory counsel.
Questions
Are you a regulatory consultant or law firm?
No. We are engineers and scientists who have built regulated clinical software. We handle the technical and evidence side of SaMD planning and work alongside your regulatory counsel or submission consultant, who owns the submission itself.
Is my product a medical device?
That depends on the claims and the intended use, not on the technology. Many digital health products can stay outside device regulation with careful claims; others cannot and should plan accordingly. The position paper answers this for your product.
What about AI and machine-learning SaMD?
We plan for model documentation, predetermined change control, and the validation data a learning system needs, and we can help source and label that data.
Related services
Scope it in 30 minutes
Book a scoping call and we'll name the smallest engagement that moves you forward. Most teams start with the fixed-scope Initial Audit.
Book a 30-min scoping callPrefer to write? Send a short note.