Medical Device Design and Regulation

  1. Post-Market Surveillance and Activities
    1. Post-Market Surveillance Plan
      1. Objectives and Scope
        1. Data Collection Methods
        2. Complaint Handling
          1. Complaint Intake and Documentation
            1. Investigation and Resolution
            2. Medical Device Reporting for Adverse Events
              1. Reporting Requirements
                1. Timelines and Procedures
                2. Corrections and Removals
                  1. Recalls
                    1. Recall Classification
                      1. Recall Execution and Communication
                      2. Market Withdrawals
                      3. FDA Inspections and Audits
                        1. Quality System Inspection Technique
                          1. Inspection Process
                            1. Key Focus Areas
                            2. Warning Letters and Enforcement Actions
                              1. Common Violations
                                1. Response and Remediation

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                            12. Labeling and Instructions for Use

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                            14. Specialized Topics in Medical Device Design