Free Introduction
Regulatory Affairs > Intermediate
AI-Powered Software as a Medical Device (SaMD) and Digital Health Compliance
Master the full regulatory lifecycle of AI-powered Software as a Medical Device (SaMD) and digital health products. This course covers FDA and EU MDR classification, IEC 62304 software development, ISO 14971 risk management, AI/ML validation under GMLP, cybersecurity for connected devices, clinical evaluation, global regulatory submissions, and post-market surveillance — all through the lens of AI-enhanced compliance workflows.
Free preview lessons available — try before you buy
What you'll learn
- Classify SaMD under FDA and EU MDR frameworks and understand regulatory oversight
- Apply IEC 62304 software life cycle processes and safety classifications
- Conduct ISO 14971 risk management for medical device software and AI systems
- Validate AI/ML models following Good Machine Learning Practice (GMLP) principles
- Implement cybersecurity controls and manage post-market vulnerabilities
- Prepare pre-market submissions (510(k), De Novo, PMA, CE Marking) for SaMD
- Design clinical evaluation plans and generate clinical evidence for AI diagnostics
- Execute post-market surveillance, adverse event reporting, and lifecycle management
Course content
Welcome and Course Roadmap
Defining Software as a Medical Device (SaMD) under IMDRF Guidelines
Distinguishing GxP/CSV Software from SaMD & Digital Health Products
The Digital Health Landscape: Wearables, DTx, and AI Diagnostics
Health Authority Oversight: FDA Digital Health Center of Excellence
Classifying SaMD: FDA Class I/II/III vs. EU MDR Class IIa/IIb/III
General Safety and Performance Requirements (GSPR) for Software
Establishing a Medical Device Quality Management System (ISO 13485)
IEC 62304 Overview: Software Life Cycle Processes for Medical Devices
Software Safety Classification: Class A, B, and C under IEC 62304
Requirements
- Basic understanding of pharmaceutical or medical device regulatory concepts
- Familiarity with quality management systems (QMS) concepts is helpful but not required
Description
Master the full regulatory lifecycle of AI-powered Software as a Medical Device (SaMD) and digital health products. This course covers FDA and EU MDR classification, IEC 62304 software development, ISO 14971 risk management, AI/ML validation under GMLP, cybersecurity for connected devices, clinical evaluation, global regulatory submissions, and post-market surveillance — all through the lens of AI-enhanced compliance workflows.
This course is designed for:
- Regulatory affairs professionals entering the digital health or SaMD space
- Quality assurance specialists working on medical software products
- Clinical data managers and clinical operations staff at digital health companies
- Software developers and engineers building AI-powered medical devices
- Compliance officers and auditors at MedTech and digital therapeutics companies
Instructor
SafeMeds Academy
Life-science curriculum specialist
Practical training for pharma, biotech, CRO, regulatory, clinical, PV, market access, medical writing, data, and AI-enabled teams across the globe.
How to earn your certificate
- Watch the lessons. Each lesson is marked complete automatically once you have watched 90% of its video — there is no button to click.
- Reach 100%. When all 60 lessons are complete, the final quiz unlocks in your course player and dashboard.
- Pass the final quiz. 20 multiple-choice questions, 70% to pass (14/20), with unlimited retries.
- Get your certificate. It is issued to your account automatically, emailed to you, and verifiable online.