What You’ll Learn: Medical AI Compliance
You’ll go from understanding advanced AI models to mastering the rigorous regulatory documentation and processes required for deploying AI as a medical device.
FDA 510(k) Process
Learn the step-by-step requirements and documentation needed for a 510(k) submission.
Software as a Medical Device (SaMD)
Understand the specific regulatory considerations for AI software used in healthcare.
Design History Files (DHFs)
Compile comprehensive DHFs detailing the design and development of your AI software.
ISO 13485 Integration
Integrate your AI development process with ISO 13485 quality management standards.
Who Is This Course For?
Ideal for experienced AI engineers, medical device developers, and regulatory affairs professionals working on AI-powered healthcare products.
- AI engineers building medical software (SaMD)
- Regulatory specialists in medical devices
- Product managers for AI healthcare startups
Hands-On Projects
Mock 510(k) Submission Package
Build a complete, mock 510(k) submission for a hypothetical AI diagnostic tool.
AI Software Design History File
Create a detailed DHF documenting the design and development of an AI-powered medical application.
Capstone
Regulatory Compliance Plan
Develop a comprehensive plan integrating ISO 13485 and FDA requirements into an AI development lifecycle.
2-Week 510(k) & SaMD Workshop Syllabus
~24 hours total • Lifetime LMS access • 1:1 mentor support
Week 1: Regulatory Framework & Standards
- Introduction to FDA medical device regulation (Class I, II, III)
- Understanding the 510(k) pathway for AI/ML software
- Software as a Medical Device (SaMD) classification and guidelines
- Overview of ISO 13485 and its application to software
Week 2: DHFs, Documentation & Submission
- Compiling Design History Files (DHFs) for AI software
- Software validation and verification requirements
- Creating technical documentation and risk analysis
- Finalizing the mock 510(k) submission package
NSTC‑Accredited Certificate
Share your verified credential on LinkedIn, resumes, and portfolios.
Frequently Asked Questions
Prior experience with medical software development or regulatory processes (FDA, ISO) is helpful but not mandatory. A strong understanding of AI/ML and Python is essential. We will cover the necessary regulatory and medical device concepts.
No, you will not submit a real 510(k). However, you will work through the entire process, building a complete mock submission package including Design History Files (DHFs) and ISO 13485 documentation.
