Assess whether your QMS evidence connects core audit processes with the country-specific regulatory tasks tested under MDSAP. Capture readiness and evidence notes in one browser-based worklist.
Check whether processes are implemented, not merely documented.
Inputs stay locally in your browser and never call an API.
Verify findings against licensed and official source materials.
Assess implementation and objective evidence for each area. Your notes stay in this browser and are never sent to an API.
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Evidence to sample: Site/activity matrix, licenses and registrations, product list, organization chart, outsourced-process map, prior audit scope.
Evidence to sample: Quality objectives, management reviews, regulatory updates, resource decisions, organization/authority records, action tracking.
Evidence to sample: Risk files, process-risk methods, traceability to controls, change assessments, post-market updates, escalation criteria.
Evidence to sample: Audit program, KPI/trend analysis, NCR/CAPA files, root cause, effectiveness results, recurring-issue analysis.
Evidence to sample: Design file, trace matrix, V&V, reviews, transfer evidence, change records, essential-principles or GSPR mapping.
Evidence to sample: Batch/traveler records, validated processes, environmental logs, identification/traceability, release and service records.
Evidence to sample: Supplier evaluations, quality agreements, scorecards, audits, specifications, acceptance records, supplier-change files.
Evidence to sample: TGA entries, ANVISA records, Canadian licences, Japan approvals/certifications, FDA listings, renewal/change logs.
Evidence to sample: Reportability decisions, jurisdictional submissions, recall/advisory files, timelines, communications, effectiveness checks.
Evidence to sample: Sponsor agreement, ARTG evidence, TGA correspondence, incident/recall assessments, change notifications.
Evidence to sample: ANVISA records, BRH agreement, BGMP evidence, technical-responsibility records, NOTIVISA/field-action files.
Evidence to sample: MDL/MDEL evidence, licence changes, mandatory-report files, recall records, MDSAP certificate/scope.
Evidence to sample: MAH agreement, product authorization, QMS certificate, change assessments, PMDA/MHLW communications, vigilance files.
Evidence to sample: Registration/listing, 510(k)/PMA/De Novo evidence, MDR files, 806 assessments/reports, device tracking where applicable.
The score summarizes reviewed items only. It is not an audit grade or certification prediction.
Sample records across products, sites, shifts, and time periods. Look for consistent execution, traceability between connected processes, competent decision makers, and evidence that actions were effective.
Use every partial or gap result as a work item with an owner, target date, containment where needed, root-cause depth proportionate to risk, and an effectiveness check. Revisit the assessment after changes are implemented.
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.
No. MDSAP audits a medical device QMS using a defined audit model that incorporates ISO 13485 and participating-country regulatory requirements.
No. This is a high-level readiness assessment using paraphrased process prompts. Audit organizations and regulators use current official MDSAP documents and jurisdictional requirements.
Selections and evidence notes stay in this browser and are not uploaded. Download the text summary to share the worklist internally.
