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.
Incorrect classification is the most expensive mistake in MedTech. Our team draws on 20+ years of cross-market experience to identify the optimal regulatory pathway and predicate strategy from day one.
Discuss Your DeviceCompliance isn't about paperwork; it's about efficiency. We build quality systems that satisfy auditors without slowing down your engineering team.
Our ISO 13485:2016 compliant QMS implementations are designed for startup agility — scalable, audit-ready, and built to grow with your company from prototype to commercial launch.
Build Your QMSWe 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.
Every hazard analysis is built with the end-patient in mind, delivering defensible documentation that withstands the most rigorous Notified Body or FDA scrutiny.
Start Risk ManagementDoes 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.
Our clinical evaluation reports (CER) are built to EU MDR Article 61 standards and our V&V protocols are designed to generate the evidence base that regulators expect.
Plan Your Clinical StrategyThe final push. We manage pre-submission meetings (Q-Subs), coordinate with Notified Bodies, and prepare your team for the specific scrutiny of global regulators.
Our team has managed FDA Q-Sub interactions and Notified Body technical reviews across all device classes. We know what reviewers look for — and how to present your submission to close without deficiencies.
Plan Your SubmissionWhether you're finalising a concept or preparing a submission, our technical experts ensure you cross the finish line with confidence.
Book a Free AssessmentFDA pathway, EU MDR class, predicate strategy — we get this right from day one.
ISO 13485 compliant, audit-ready, built for startup speed.
510(k), De Novo, PMA, EU MDR — end-to-end execution.