Free download · Lead consultant's working checklist
The MDA Gap Analysis Checklist
The same readiness checks we run on day one of a paid engagement — yours to run internally first. Fill in the form and we send the checklist to your WhatsApp or email, usually within the hour during business time.
What's inside
40+ checks across the five failure zones
- Classification & grouping — is your class defensible, and are you overpaying by not grouping devices?
- Technical documentation — the CSDT items CABs query most, and the evidence gaps that stall reviews for months.
- Licensing prerequisites — establishment license, GDPMD or ISO 13485 status, and role declarations that must match reality.
- Labeling & IFU — the Malaysian labeling checks importers routinely miss on foreign-made devices.
- Post-market readiness — the complaint, vigilance and traceability records an auditor asks for in the first ten minutes.
Run it honestly and you will know — before spending a ringgit on consultants — whether you are weeks or quarters away from a submission MDA will accept. Many companies use it and proceed on their own; the ones with real gaps tend to call us. Both outcomes are fine with us.
We use your details only to send the checklist and follow up once. No mailing lists, no drip campaigns.
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We use these details only to send the checklist and follow up once. No mailing lists.