From concept and classification to design controls, risk management, and pre-submission planning, we provide the deep technical expertise MedTech startups need to avoid costly regulatory pitfalls and accelerate time-to-market.
The foundation of your regulatory journey. We determine exactly how the FDA or EU MDR views your technology — a decision that dictates your entire development budget and timeline.
Compliance isn't about paperwork; it's about efficiency. We build quality systems that satisfy auditors without slowing down your engineering team.
We integrate ISO 14971 risk management into every phase of development. Our approach ensures your technical file isn't just a compliance requirement, but a robust engineering asset.
Does the device do what you say it does? We manage the critical transition from prototype to evidence-based product, ensuring all testing satisfies international standards.
The final push. We manage pre-submission meetings (Q-Subs), coordinate with Notified Bodies, and prepare your team for the specific scrutiny of global regulators.
Whether you're finalizing a concept or preparing a submission, our technical experts ensure you cross the finish line with confidence.
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