From SaMD qualification & classification to EHDS and data governance, we help healthtech companies understand exactly what's required and build the most efficient path to compliance.
Establishing your SaMD classification under EU MDR is the foundation of your entire regulatory strategy. Getting this wrong costs months. We work through the decision tree with you, establish the right pathway, and support you through the full conformity assessment journey.
Health AI systems fall under the EU AI Act's high-risk classification (Annex III). This means conformity assessment, registration in the EU database, and ongoing QMS obligations. We help you understand the obligations and design a proportionate response.
Health data is special category under GDPR. The European Health Data Space (EHDS) is adding a new layer of primary and secondary use obligations. We help you build the right data governance architecture from the start.
ISO 13485 is the entry requirement for any software medical device going to market. We support you through initial gap analysis, QMS design, and mock audit so the real audit is a formality.
Monthly regulation updates · Compliance Call Access · Horizon Scanning for Upcoming Changes · Quarterly Review.
Clare stays across everything so you don't have to.
Clare is happy to take an initial call — no obligation, no generic sales process.
