MedTech Regulatory Masterclass

This comprehensive nine-module programme equips MedTech professionals with the regulatory, technical, and quality expertise required to design, develop, and maintain compliant software as a medical device (SaMD), including advanced AI/machine learning (ML) systems. Designed for engineers, regulatory and quality specialists, founders, and cross-functional product teams, the course provides an end-to-end understanding of global medical device frameworks, including ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, the EU Medical Device Regulation (MDR), EU In Vitro Diagnostic Medical Device Regulation (IVDR) and the EU AI Act.

Learners gain applied skills across quality management, software lifecycle processes, usability engineering, clinical evaluation, risk management, and AI-specific regulatory and development requirements. Through structured modules supported by practical examples and documentation templates, participants learn to plan regulatory pathways, implement compliant development processes, and produce high-quality technical documentation.

Deep tech components are introduced throughout the programme, including software architecture, risk-based classification, model validation, data governance, transparency and explainability, and performance evaluation of AI as medical devices. The curriculum integrates both European and global perspectives to ensure learners are prepared to navigate evolving regulations.

The programme is delivered fully online and self-paced, enabling flexible upskilling for working professionals. Learners can apply for the course through a simple online application form, available via the dedicated course webpage. Evaluation consists of mandatory viewing of all module lessons, short inter-module self-assessment quizzes, and a remote computer-validated final exam that determines the course grade. An optional live Q&A session (and Q&A forum) are available for additional support.

Upon completion, participants will have the competencies to manage regulatory-compliant software and AI products from conception to post-market activities, accelerating safe and effective innovation in digital health and MedTech.