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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
Teach online with
Unit 1 Quiz
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