We are pleased to invite you to the NoBoCap & IRHIS Online Workshop: From Innovation to CE-Marking: Smart NoBoCap E-Tools for HealthTech, MedTech and Digital Health SMEs   This workshop will present practical NoBoCap e-tools designed to support HealthTech, MedTech and Digital Health SMEs/ Startups in understanding MDR/IVDR regulatory requirements and preparing for the CE-marking…

07 May 2026 | 10:00–11:15 | Online Navigating the shifting regulatory landscape: EU MDR/IVDR, FDA QMSR, and what it means for your QMS The regulatory framework for medical devices is undergoing significant transformation on both sides of the Atlantic. The EU MDR and IVDR are being revised to address the risk of supply shortages and…

Module 2 – Generating Data for Technical Documentation (MDR) is part of the NoBoCap postgraduate training programme dedicated to strengthening regulatory expertise in the European medical devices sector. This 10-week, 100% online course focuses on the generation of data required for MDR-compliant technical documentation, providing participants with practical knowledge relevant for regulatory affairs, clinical evaluation,…