We define your regulatory pathway under EU MDR, UK MDR, and FDA frameworks, from device classification and clinical evaluation through to notified body engagement and CE marking. A defined plan with measurable milestones, 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 clinics, embedded in your team, translating complex regulatory requirements into clear decisions you can act on.
Many of our clients come from technology, business, or consumer backgrounds. That’s not a barrier. It’s precisely where senior clinical and regulatory expertise adds the most value.
We build DCB0129 and DCB0160 compliant clinical safety frameworks for digital health products and SaMD. Hazard workshops, safety cases, and hazard logs, structured, auditable, and built to withstand 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, bringing the same rigour and standard of work to every engagement, regardless of jurisdiction or scale.