Post-Market Surveillance / Feedback SOP

[mlehotay]

Define procedures for monitoring deployed software, handling complaints, and collecting feedback.

Checklist:

• Feedback collection process (user reports, bug tracking).
• Analysis and classification of issues.
• Trigger CAPA or improvement actions.
• Reporting and record-keeping.

Acceptance Criteria:

• SOP exists in wiki.
• At least one simulated feedback or complaint logged and tracked.