This service offers tailored regulatory support to EIC innovators developing medical devices, IVDs, or digital health solutions. Clients can choose one or more services based on their stage of development and specific needs. Support begins with Regulatory Strategy and Roadmap Development, where we help define the product’s intended use, classification, and applicable EU/FDA requirements, delivering a customised roadmap for certification and market access. We also offer Quality Management System (QMS) Implementation and Support, assisting with ISO13485-compliant system setup, documentation, and internal training. For teams preparing for regulatory submission, our Technical File Development and Risk Analysis service provides guidance on assembling a compliant Technical File, conducting risk assessments, and addressing General Safety and Performance Requirements (GSPR). Our Clinical Evaluation and Validation Strategy service supports the design of clinical protocols and validation plans, ensuring alignment with EU and FDA expectations. After market entry, innovators can rely on our Post-Market Surveillance and Continuous Compliance service to maintain certification, manage complaints, and adapt to regulatory updates. For frontier technologies, our Specialised Consultancy for AI and Biomarker-Based Devices addresses the specific regulatory challenges of machine learning algorithms and diagnostic software, ensuring integration of clinical and technical requirements. All services are delivered by experienced consultants and can be provided online or on-site, depending on the client’s preference. This flexible, expert-driven approach helps innovators navigate complex regulatory landscapes efficiently and with confidence.