A selection of engagements across clinical safety, pharmacy governance, and medical device regulation. All anonymised in line with client confidentiality.
A pre-seed femtech startup had developed a novel bioelectronic medical device targeting women’s pelvic pain and dysmenorrhea. With a CE marking target under EU MDR 2017/745 as a Class IIa device, the founding team had no internal regulatory or clinical safety expertise. They needed a strategy, not a framework.
Kapinga took full ownership of the regulatory workstream from the outset. Device classification was confirmed under EU MDR 2017/745, the CE marking pathway defined, and a product development task matrix built across eight parallel workstreams covering hardware engineering, biocompatibility, clinical evaluation, quality management, and usability, each with defined milestones and a phased timeline through to submission. A Clinical Evaluation Plan was scoped, a SOTA literature review strategy defined, and notified body outreach initiated. Critical compliance gaps were identified across hardware, biocompatibility, and QMS readiness, and documented with mitigation strategies embedded directly into the development roadmap. The founding team received clear, stage-appropriate regulatory direction at every point, translated into decisions they could act on and investors could rely on.
Investor-credible regulatory strategy in place.
CE marking pathway defined. Notified body engagement initiated.
Phased development roadmap built and aligned to EU MDR 2017/745.
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.
Risk-stratified governance recommendations delivered across multiple services.
Prescribing models strengthened.
Patient safety exposure reduced.
Regulatory alignment improved.
Kapinga embedded directly into the organisation as the senior clinical lead, taking ownership of governance architecture across multiple high-risk prescription pathways simultaneously. Patient eligibility frameworks and clinical questionnaires were designed from the ground up, built to identify contraindications, manage risk, and satisfy GPhC, CQC, and MHRA requirements without creating friction in the patient journey. Prescriber pathway documentation was developed and implemented, with compliance against ASA/CAP Code requirements assessed and embedded into marketing and operational processes. KPI infrastructure was established to enable ongoing clinical oversight and auditability. Clinical safety thinking was integrated at every stage, from initial patient assessment through prescribing, dispensing, and follow-up, ensuring the service was built to withstand regulatory scrutiny from day one.
Full clinical governance infrastructure delivered across multiple prescription pathways.
GPhC, CQC, MHRA, and ASA/CAP compliant.
Auditable, scalable, and operational from launch.
A femtech platform for women living with persistent and chronic symptoms was in early-stage product development. The platform brings a woman’s data together across six health pillars: hormones, sleep, movement, gut health and nutrition, stress, and mental health, and decodes the drivers behind her good and bad days. As the product took shape, the team needed senior clinical input to establish clear boundaries between health information and regulated medical claims, and to embed clinical safety thinking from the very foundations of the product.
Kapinga embedded as the senior clinical lead, bringing regulatory and clinical safety expertise directly into the product development process at the point where it matters most, before architectural decisions become difficult and costly to reverse.
Patient journeys were mapped and stress-tested against regulatory requirements, with clinical risk identified and addressed at the design stage rather than retrospectively. Clear positioning boundaries were established between health-tracking functionality and regulated medical services, protecting the organisation from inadvertent regulatory exposure. User research was supported and interpreted through a clinical lens, ensuring insights translated into compliant, defensible product decisions. A product architecture was defined that gave the team a clear path to market, built on clinical rigour without compromising the user experience.
The result was a foundation strong enough to build on. The platform has since progressed toward becoming a Class I Software as a Medical Device in the UK, a separate regulatory workstream undertaken independently of this engagement, but one made possible by the clinical discipline established from day one.
A clinically grounded product roadmap, delivered.
Regulatory positioning defined, defensible, and audit-ready.
A compliant product architecture in place from day one.
