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.
Ongoing senior clinical and regulatory expertise for organisations that need continuous support without a full-time hire.
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.
A series of distance-selling pharmacies delivering remote prescribing and dispensing services, including higher-risk medications, required an independent clinical governance review. Each operated a fully digital patient journey with questionnaire-led prescribing and limited existing oversight frameworks.
Kapinga conducted structured clinical governance audits across each service, reviewing prescribing models, SOPs, clinical questionnaires, and patient pathways against GPhC standards and digital health best practice. Particular scrutiny was applied to questionnaire-led supply of higher-risk treatments, where the absence of real-time clinical oversight creates the greatest patient safety exposure. Prescriber oversight structures, escalation pathways, and documentation quality were assessed across each organisation. Findings were risk-stratified and translated into targeted, implementable recommendations, prioritised by patient safety impact and regulatory exposure rather than operational convenience.
Risk-stratified governance recommendations delivered across multiple services.
Prescribing models strengthened.
Patient safety exposure reduced.
Regulatory alignment improved.
A regulated online pharmacy and wellness business expanding into prescription services needed a clinical and operational governance framework built from scratch. Operating across cannabis-based medicinal products, GLP-1, and TRT pathways, the organisation required senior pharmacy expertise embedded across compliance, patient safety, and operational design.
Kapinga led clinical governance across multiple workstreams — patient eligibility frameworks, clinical questionnaire design, prescriber pathway documentation, and KPI infrastructure. Compliance across CQC, GPhC, MHRA, and ASA/CAP Code requirements was assessed and embedded into operational processes. Clinical safety thinking was integrated across the full patient journey, from initial assessment through to dispensing and follow-up.
A fully operational clinical governance structure across prescription pathways. Compliant, auditable, and built to scale.
A selection of engagements across clinical safety, pharmacy governance, and medical device regulation. All anonymised in line with client confidentiality.
Kapinga led the full regulatory workstream. Device classification was established, the CE marking pathway defined, and a product development task matrix built across eight workstreams with a phased timeline through to submission. Clinical Evaluation planning, SOTA literature review strategy, and notified body outreach were initiated. Critical gaps across hardware engineering, biocompatibility, and quality management were identified and documented, with mitigation strategies built into the development roadmap.
A structured, investor-credible regulatory strategy. Defined CE marking pathway. Notified body engagement underway. Phased development roadmap aligned to EU MDR 2017/745.