← Case studies FDA & Regulatory Strategy
Choosing the right FDA path before the first PCB spins
Classification, predicate strategy, and design controls timed to engineering—not bolted on after freeze.
Challenge
Teams often treat regulatory strategy as a post-engineering problem. That produces rework: wrong claims, missing design controls, and V&V plans that do not match the intended use.
Approach
- Map intended use, indications, and risk class early—before architecture lock.
- Decide 510(k), De Novo, or exempt path with a written rationale and predicate landscape.
- Stand up design history file (DHF) structure, risk management (ISO 14971), and design controls that engineering can actually live in.
- Align labeling, cybersecurity, and clinical evidence needs with the software and hardware roadmap.
- Build a gated plan: concept → design freeze → verification → validation → submission package.
Outcomes
- Engineering and regulatory work on the same schedule instead of fighting each other.
- Clear decision record for investors, partners, and FDA pre-sub conversations.
- Fewer late-stage surprises when claims and residual risk finally meet the product.
What this demonstrates
FDA strategy · Design controls · Risk management · Pre-sub readiness