This course was created with the
course builder. Create your online course today.
Start now
Create your course
with
Autoplay
Autocomplete
Previous Lesson
Complete and Continue
Overview of Software as a Medical Device - Quality Systems and Regulatory Compliance
Course Introduction
Welcome to Fission University
Unit 1: Introduction to Software as a Medical Device
Definition of SaMD Medical Device
Determining whether an application is SaMD
Unit 1 Quiz
Unit 2: FDA Regulations
Quality System Requiements
Premarket approvals and clearances: 510(k), DeNovo, and PMA
Investigational Device Exemptions
Unit 2 Quiz
Unit 3: Global Regulation of SaMD
International Medical Device Regulators Forum
Medical Device Single Audit Program (MDSAP)
Evolution in EU - Consequences of EU MDR on SaMD
Unit 3 Quiz
Unit 4: AI-ML Enabled Devices
Defining AI-ML
Special Considerations for AI-ML Enabled Devices
Unit 4 Quiz
Unit 5: Using AGILE for SaMD
Development Processes - AGILE vs Waterfall
Unit 5 Quiz
Unit 6: Cybersecurity Requirements for SaMD
FDA Requirements for Cybersecurity in Medical Devices
Unit 6 Quiz
Conclusion
Conclusion
Determining whether an application is SaMD
Lesson content locked
If you're already enrolled,
you'll need to login
.
Enroll in Course to Unlock