Overview
Software as a Medical Device (SaMD) represents one of the fastest-growing segments in the medical device industry, yet classification and regulatory pathways differ significantly between the US FDA and European MDR systems. This 90-minute webinar provides a systematic comparison of SaMD classification approaches, from the IMDRF framework to FDA's risk-based categorization and EU MDR Rule 11. Participants will learn to correctly classify their software products and select the appropriate regulatory pathway in both jurisdictions, avoiding common mistakes that lead to delays and compliance issues.
This compact 90-minute course provides a focused comparison of SaMD classification and regulatory pathways in the US and EU markets. Participants will learn the IMDRF framework, FDA's approach to software regulation including the recent Digital Health Software Precertification Program developments, and EU MDR requirements with special attention to Rule 11 and MDCG guidance documents. The course emphasizes practical classification exercises and pathway selection strategies.
Why Should You Attend
- Master the IMDRF SaMD classification framework used globally
- Understand FDA SaMD guidance and risk categorization
- Apply EU MDR Rule 11 correctly for software classification
- Compare 510(k), De Novo, and PMA pathways with EU conformity routes
- Avoid common classification errors that delay market access
- Develop dual-market regulatory strategies for software products
Webinar Takeaway
1. Introduction to SaMD Regulation
- Definition of SaMD vs. SiMD (Software in a Medical Device)
- IMDRF SaMD framework and global harmonization
- Regulatory trends and recent guidance updates
2. FDA SaMD Classification & Pathways
- FDA risk-based classification for software
- 510(k), De Novo, and PMA pathways for SaMD
- Clinical Decision Support (CDS) software exemptions
- FDA Digital Health Center of Excellence initiatives
- Pre-submission strategies and FDA meetings
3. EU MDR Classification for Software
- MDR Rule 11 deep dive and practical application
- MDCG 2019-11: Guidance on qualification and classification
- MDCG 2020-1: Clinical evaluation of medical device software
- Role of Notified Bodies in SaMD assessment
- Technical documentation requirements
4. Comparative Analysis & Strategy
- Side-by-side comparison of classification outcomes
- Documentation strategies for dual submissions
- Timeline and resource planning
- Common pitfalls and how to avoid them
5. Practical Case Studies
- Classification exercises with real-world examples
- Pathway selection decision tree
- Q&A and discussion
Who Will Benefit
- Regulatory Affairs professionals working with software products
- Product managers of digital health solutions
- Quality managers responsible for SaMD compliance
- Software development leads entering regulated markets
-
Startup founders developing medical software
Faculty Dr. H.C. Frank Stein
Prof. Dr. H.C. Frank Stein, medical engineer, medical engineering experience for 30 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in medical and healthcare software, artificial intelligence and machine learning in healthcare and medicine, ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Latin-America, Asia, Australia, Latin-America
