FDA 510(k) Clearance
Predicate strategy and eSTAR-ready submission planning for first-time sponsors.
Startups & Early Stage
Seed to Series C — regulatory strategy investors want to see.
How we serve Startups & Early Stage.
Early-stage medical technology companies do not need generic consulting - they require a regulatory operating system that investors, engineers, clinicians and regulators can rely on.
We support founders from concept through classification, product claims, predicate strategy, development planning, QMS foundation, design controls, pre-submission strategy, investor diligence, and first regulatory milestone.
We help startups avoid expensive mistakes before the first FDA or Notify Body meeting (wrong intended use, weak predicate logic, missing design history, unvalidated testing, premature clinical claims, underdeveloped QMS and unclear market pathway).
The result is a sharper regulatory story; cleaner development plan; company that appears fundable, credible and executable
FDA Classification and Product Code Strategy
FDA 510(k), De Novo and PMA pathways
FDA Q-Submission Program
EU MDR / EU IVDR classification
ISO 13485 foundation
ISO 14971 risk management
Design Controls (21CFR part 820.30)
IEC 62366-1 Human Factors
Investor and diligence-ready regulatory strategy
Where we typically engage with Startups & Early Stage clients.
Service detail
FDA De Novo Classification
First-of-kind pathway strategy for novel low-to-moderate risk technologies.
Quality Management Systems
Lean ISO 13485 / QMSR foundations built for startup execution.
AI in MedTech Regulatory
AI/ML SaMD, PCCP and software regulatory strategy for digital health startups.