# MDSAP gap analysis worksheet

Prepared by: ____________________  Date: __________  Version: __________

Sites: ____________________
Device families: ____________________
Target markets: ____________________
Outsourced activities: ____________________

Use one row per gap. Store confidential evidence in your own controlled workspace.

| Reference and market | Evidence link and version | Observed gap | Action | Owner | Due date | Closure evidence | Status |
|---|---|---|---|---|---|---|---|
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |

Status: open / in progress / ready for review / closed.
Record and justify any not-applicable decision.

Closure reviewed by: ____________________  Date: __________
Remaining actions: ____________________

Preparation aid from AA Alive Sdn Bhd; this worksheet is not a certification or regulatory approval.
Instructions and official source links: https://www.medicaldeviceconsultant.my/mdsap-gap-analysis-checklist