We define your EU MDR regulatory pathway and get you to CE marking. Classification, clinical evaluation, notified body engagement — a clear plan, not a holding position.
Kapinga is a founder-led clinical safety and regulatory consultancy. We work directly with healthtech companies, wellness businesses moving into regulated services, and online pharmacy platforms — embedded in your team, focused on what moves things forward. Many of our clients are founders without a clinical or regulatory background. That’s not a problem. It’s exactly where we add the most value.
We build DCB0129 and DCB0160 compliant clinical safety frameworks for digital health products. Hazard workshops, safety cases, and hazard logs — structured, auditable, ready for regulatory scrutiny.
We review websites, marketing materials, and digital platforms against MHRA, ASA/CAP Code, GPhC, and CQC standards – identifying non-compliant claims, misleading positioning, and regulatory risk before they become enforcement issues.
Kapinga has delivered clinical safety and regulatory engagements across the UK,
European Union, United States, and UAE. The same standard of work, regardless of jurisdiction.