AI MDSAP Evidence Gap Review
State the MDSAP markets in scope and paste your QMS, authorization, vigilance, audit, and supplier evidence. The agent inventories the material, connects core QMS processes to market-specific tasks, and returns a prioritized gap report.
Paste your QMS and market evidence
State the participating markets in scope, then paste your site and product scope, QMS evidence, registrations, complaint/vigilance controls, prior audit findings, or evidence index.
What to paste for a useful review
Include document names and excerpts that show how processes operate: recent sampled records, audit findings, CAPA effectiveness, management decisions, supplier monitoring, complaint or vigilance decisions, and other objective evidence. A document index alone can identify missing coverage, but it cannot demonstrate implementation.
Separate sources with simple headings and state the products, sites, outsourced processes, and markets in scope. The report distinguishes an explicit deficiency from an area that simply could not be assessed from the material provided.
- What countries participate in MDSAP?
- The participating regulatory-authority markets covered by this tool are Australia, Brazil, Canada, Japan, and the United States. Applicability depends on where the manufacturer markets devices and its regulatory roles.
- Is MDSAP the same as ISO 13485 certification?
- No. MDSAP audits a medical device QMS using a defined audit model that incorporates ISO 13485 and participating-country regulatory requirements.
- Is this an official MDSAP audit model?
- No. This is a high-level readiness assessment using paraphrased process prompts. Audit organizations and regulators use current official MDSAP documents and jurisdictional requirements.