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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
7.
Risk Management
7.1.
Risk Management Plan
7.1.1.
Scope and Objectives
7.1.2.
Roles and Responsibilities
7.1.3.
Criteria for Risk Acceptability
7.2.
Risk Analysis
7.2.1.
Intended Use and Foreseeable Misuse
7.2.2.
Identification of Hazards
7.2.2.1.
Biological Hazards
7.2.2.2.
Mechanical Hazards
7.2.2.3.
Electrical Hazards
7.2.2.4.
Software-Related Hazards
7.2.3.
Estimation of Risk for Hazardous Situations
7.2.3.1.
Severity Assessment
7.2.3.2.
Probability Assessment
7.3.
Risk Evaluation
7.3.1.
Risk Acceptability Criteria
7.3.2.
Risk-Benefit Analysis
7.4.
Risk Control
7.4.1.
Inherent Safety by Design
7.4.2.
Protective Measures in the Device
7.4.3.
Protective Measures in Manufacturing Process
7.4.4.
Information for Safety
7.4.4.1.
Labeling
7.4.4.2.
Instructions for Use
7.4.5.
Verification of Risk Control Measures
7.5.
Evaluation of Overall Residual Risk
7.5.1.
Aggregation of Residual Risks
7.5.2.
Benefit-Risk Analysis
7.6.
Risk Management Report
7.6.1.
Documentation Requirements
7.6.2.
Review and Approval
7.7.
Production and Post-Production Information
7.7.1.
Collection of Feedback
7.7.2.
Trending and Analysis
7.7.3.
Updating the Risk Management File
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8. Materials and Biocompatibility