Program Overview
This program equips participants with a deep understanding of regulatory expectations and practical strategies for achieving market authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW). Led by an industry expert with 25+ years of global experience, the course blends regulatory frameworks (EU MDR/IVDR, US FDA, IMDRF, CDSCO), real-world approval case studies, and hands-on classification exercises. Participants will learn how to manage risk classes, generate clinical and cybersecurity evidence, and develop regulatory strategies that accelerate product approvals while avoiding common compliance pitfalls.
Features
- Interpret global regulatory frameworks for SaMD and MDSW (EU, FDA, IMDRF, India).
- Accurately classify software products and map appropriate authorisation pathways.
- Build strong clinical, technical, and cybersecurity evidence packages for submission.
- Anticipate and mitigate risks leading to regulatory rejections and recalls.
Target audiences
- Regulatory Affairs and Quality Assurance Teams
- Professionals in Clinical Affairs, R&D
- Professionals in IT/Software Engineering
Curriculum
- 5 Sections
- 22 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- What is SaMD & MDSW?5
- 1.1SaMD (IMDRF), MDSW (EU MDR), Embedded Software vs Standalone Software.
- 1.2Intended Use, Clinical Evaluation, Risk Classes (I–III), GxP, IEC 62304, ISO 14971.
- 1.3Global regulatory bodies: FDA, EMA, CDSCO, TGA, PMDA, NMPA.
- 1.4Key Concept: Digital Therapeutics & Cybersecurity by Design
- 1.5Human Factors Engineering & Real-World Evidence (RWE)
- Regulatory Pathways & Challenges6
- 2.1EU MDR & IVDR: MDSW classification, conformity assessment routes, notified body reviews
- 2.2US FDA: 510(k), De Novo, PMA pathways for SaMD
- 2.3Emerging frameworks: IMDRF guidance, UK MHRA Software as a Medical Device regulations
- 2.4Why regulators reject SaMD submissions – case insights
- 2.5Common challenges: Classification Confusion & Inadequate Clinical Evidence; Cybersecurity Gaps & AI/ML-based SaMD evolving post-market
- 2.6
- Real-Life Case Sharing4
- Interactive Exercises & Simulation3
- Wrap-Up & Key Takeaways4
- 5.1Market authorisation is a continuous lifecycle activity (not one-time).
- 5.2Clinical evaluation, risk management, and cybersecurity evidence are non-negotiable.
- 5.3Global harmonisation is growing, but regional nuances remain critical.
- 5.4Early regulatory planning accelerates market access & patient adoption.
Instructor
