Regulatory work can feel intimidating when you’re trying to build momentum, grow your product, and manage limited time and resources. I’m here to make the compliance side feel lighter, clearer and much more manageable.

• Practical support — With 8+ years helping Class I, IIa and IIb devices through CERs, PMCF, risk files and MDR remediation, I focus on what actually matters for your next step.
• Clinical evaluation made approachable — I’ve authored many CERs and guided teams through literature appraisal, benefit–risk work and evidence mapping — always breaking things down into clear, achievable tasks.
• Risk and clinical in one place — Instead of treating risk and clinical evidence as separate worlds, I help you bring them together so your documentation feels coherent and aligned.
• Documentation that reviewers understand — As an ISO 13485 Lead Auditor, I help shape your files in a way that makes sense to auditors and NB reviewers — without over‑engineering anything.
• A scientific background you can lean on — With a PhD in Biology, I translate complex scientific information into straightforward, reviewer‑friendly narratives that support your claims.
• A supportive partner for your team — I collaborate closely with founders, engineers, QA and regulatory teams, making sure everyone understands what’s needed and why, so no one feels lost in the process.

My aim is simple: to give you clarity, confidence and a strong compliance foundation — so you can focus on building technology that truly makes an impact.