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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
10.
Clinical Evaluation and Trials
10.1.
Clinical Evaluation Report
10.1.1.
Literature Review
10.1.2.
Clinical Data Analysis
10.1.3.
Equivalence Assessment
10.2.
Investigational Device Exemption
10.2.1.
Application Process
10.2.2.
Sponsor and Investigator Responsibilities
10.2.3.
Monitoring and Reporting Requirements
10.3.
Clinical Trial Design and Phases
10.3.1.
Feasibility and Pilot Studies
10.3.2.
Pivotal Studies
10.3.3.
Post-Market Clinical Follow-up
10.4.
Good Clinical Practice
10.4.1.
Principles of GCP
10.4.2.
Compliance and Monitoring
10.5.
Institutional Review Board
10.5.1.
Role and Responsibilities
10.5.2.
Review Process
10.6.
Informed Consent
10.6.1.
Elements of Informed Consent
10.6.2.
Documentation and Process
10.7.
Data Analysis and Statistical Methods
10.7.1.
Study Endpoints
10.7.2.
Statistical Power and Sample Size
10.7.3.
Data Management and Integrity
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9. Pre-Clinical Testing
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11. Regulatory Submission Pathways