Get approved in priority markets, fast.
As the regulatory landscape for software and AI-enabled medical devices evolves, we help you find the right way to get approval, faster.
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The challenge
Software as a medical device (SaMD) and AI-enabled medical device (AI-MD) approvals can take 12–18+ months for CE marking in the EU, or 5–8 months of FDA review time in the US. That's before accounting for the evidence generation work that has to happen first.
What we do
Regulatory strategy
Understand how to navigate Software as a Medical Device (SaMD) regulation, draft your intended use statement and understand your risk classification. Map regulatory pathways for Software as a Medical Device (SaMD) across priority markets: in the US, define the regulatory route (e.g., FDA 510(k) or De Novo), classification, and submission plan; in the EU, align with MDR requirements for CE marking; and in the UK, align with UKCA or CE recognition requirements.
Regulatory submission
Document the clinical evidence of your SaMD (clinical evaluation plans and reports) and prepare your regulatory submission in the UK, EU and US (including compliance with IEC 62304, IEC 62366-1, and IEC 82304-1).
Case studies
View all case studiesDesigning and delivering the clinical validation study for Medwise, an AI clinical search engine
Conducted a clinical validation study with 30 primary care physicians. Robust, regulator-ready evidence to meet UKCA Class I standards.
Read the case study: Designing and delivering the clinical validation study for Medwise, an AI clinical search engineDesigning a clinical investigation protocol for the post-market EU MDR requirements of a Class IIb AI platform
Designed a multi-site clinical investigation to meet the post-market clinical evidence condition attached to the platform's Class IIb EU MDR CE mark. Delivered a regulator-ready clinical investigation protocol aligned with ISO 14155 and EU MDR clinical evidence requirements, in just six weeks.
Read more: Designing a clinical investigation protocol for the post-market EU MDR requirements of a Class IIb AI platformLeading the clinical evaluation and notified body response strategy for the EU MDR certification of a Class IIa digital health platform
Rebuilt the Clinical Evaluation Plan and Report and structured the manufacturer's response to open notified body queries. Delivered a self-contained clinical evidence package spanning five indications.
Read more: Leading the clinical evaluation and notified body response strategy for the EU MDR certification of a Class IIa digital health platform