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Engineering
Biomedical Engineering
Medical Device Design and Regulation
1. Introduction to Medical Device Engineering
2. The Medical Device Lifecycle
3. Regulatory Foundations
4. Medical Device Classification
5. The Design and Development Process
6. Quality Management Systems
7. Risk Management
8. Materials and Biocompatibility
9. Pre-Clinical Testing
10. Clinical Evaluation and Trials
11. Regulatory Submission Pathways
12. Labeling and Instructions for Use
13. Post-Market Surveillance and Activities
14. Specialized Topics in Medical Device Design
Medical Device Classification
Risk-Based Classification Systems
Principles of Risk Classification
Impact on Regulatory Pathways
U.S. FDA Classification
Class I Devices
General Controls
Examples of Class I Devices
Class II Devices
General and Special Controls
Examples of Class II Devices
Class III Devices
Premarket Approval Requirements
Examples of Class III Devices
EU MDR Classification
Class I
Class IIa
Class IIb
Class III
Rules for Classification
Product Classification Databases
FDA Product Classification Database
EU Eudamed Database
Use of Databases in Regulatory Strategy
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3. Regulatory Foundations
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5. The Design and Development Process