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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
4.
Medical Device Classification
4.1.
Risk-Based Classification Systems
4.1.1.
Principles of Risk Classification
4.1.2.
Impact on Regulatory Pathways
4.2.
U.S. FDA Classification
4.2.1.
Class I Devices
4.2.1.1.
General Controls
4.2.1.2.
Examples of Class I Devices
4.2.2.
Class II Devices
4.2.2.1.
General and Special Controls
4.2.2.2.
Examples of Class II Devices
4.2.3.
Class III Devices
4.2.3.1.
Premarket Approval Requirements
4.2.3.2.
Examples of Class III Devices
4.3.
EU MDR Classification
4.3.1.
Class I
4.3.2.
Class IIa
4.3.3.
Class IIb
4.3.4.
Class III
4.3.5.
Rules for Classification
4.4.
Product Classification Databases
4.4.1.
FDA Product Classification Database
4.4.2.
EU Eudamed Database
4.4.3.
Use of Databases in Regulatory Strategy
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3. Regulatory Foundations
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5. The Design and Development Process