QMS - Medical Devices Consulting

This service provides strategic and operational support in Quality Management Systems (QMS) and regulatory compliance for medical devices and in vitro diagnostic (IVD) products. The goal of the service is to empower medtech startups, SMEs, and R&D teams across Europe to achieve market access and regulatory excellence. The service covers the full product lifecycle, from concept to commercialisation. Startups are assistedwith CE marking under EU MDR (2017/745) and IVDR (2017/746), FDA submissions (510(k), De Novo, PMA), and international market entry strategies. Our team develops and implements ISO 13485-compliant QMS frameworks, conducts internal audits, and ensures readiness for notified body inspections. Startups will also get support to create technical documentation, clinical evaluation reports (CER), and post-market surveillance (PMS) strategies, including PSUR and PMCF planning. For IVDs, we assist with performance evaluations and compliance with IVDR-specific requirements. Additionally, training and knowledge transfer are key to our approach. We deliver tailored workshops on MDR/IVDR compliance, risk management (ISO 14971), and QMS best practices to build internal capabilities for our partners. As a nimble and experienced EU-based consultancy, we offer both remote and on-site services, supporting innovative health technologies within the EIC ecosystem and beyond. Our goal is to be a trusted partner for EIC projects, enabling regulatory success and faster time-to-market for groundbreaking medical technologies.