Medical Device Design and Regulation

13.

Post-Market Surveillance and Activities

13.1.

Post-Market Surveillance Plan

13.1.1.

Objectives and Scope

13.1.2.

Data Collection Methods

13.2.

Complaint Handling

13.2.1.

Complaint Intake and Documentation

13.2.2.

Investigation and Resolution

13.3.

Medical Device Reporting for Adverse Events

13.3.1.

Reporting Requirements

13.3.2.

Timelines and Procedures

13.4.

Corrections and Removals

13.4.1.

13.4.1.1.

Recall Classification

13.4.1.2.

Recall Execution and Communication

13.4.2.

Market Withdrawals

13.5.

FDA Inspections and Audits

13.5.1.

Quality System Inspection Technique

13.5.1.1.

Inspection Process

13.5.1.2.

Key Focus Areas

13.5.2.

Warning Letters and Enforcement Actions

13.5.2.1.

Common Violations

13.5.2.2.

Response and Remediation

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12. Labeling and Instructions for Use

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14. Specialized Topics in Medical Device Design