GCP Comply – ISO 14155:2026 Clinical Compliance Platform seeking consortium for IND-03

About SetuMed & GCP Comply SetuMed is developing GCP Comply (app.setumed.eu), a clinical compliance workspace specifically engineered for medical device clinical investigations under ISO 14155:2026 — the international GCP standard aligned with EU MDR 2017/745. The platform digitises and standardises the full compliance workflow for sponsors, investigators, and clinical sites, generating audit-ready, regulator-accepted evidence across multinational studies.

This call targets improved regulatory methodologies and evidence frameworks for non-pharma health technologies (MD, IVD, AI/SaMD). GCP Comply directly addresses the regulatory science gap: lack of standardised, digitised, FAIR-compliant evidence generation infrastructure for medical device clinical investigations across the EU. Our platform is a real-world tool for producing the regulatory-grade clinical evidence that accelerators, notified bodies, and competent authorities need.

Partners we are looking for We are seeking to join or co-build a consortium of 3–5 partners including: - A university or research institute with expertise in regulatory science or health technology assessment (HTA) - A clinical site, hospital, or CRO with experience running medical device investigations - A regulatory consultancy or notified body with EU MDR / ISO 14155 expertise - Optionally: an additional SME with complementary digital health or data infrastructure capability.