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MedDeviceAudit

](/products/meddeviceaudit/reviews)

(2)5.0/5

MedDeviceAudit is an AI-powered compliance auditing platform built specifically for medical device manufacturers. It audits technical files against FDA QMSR 2026 (21 CFR Part 820), ISO 13485:2016, IEC 62304, and ISO 14971 — returning evidence-anchored findings grounded in your actual documents with SHA-256 verified citations, literal quotes, and page references. Every finding is mapped to the exact regulatory clause it evaluates. Zero-retention data policy — uploaded documents are permanently deleted after every audit. No document is ever stored, shared, or used to train AI. First audit always free with no credit card required. Plans from $495 per month for 5 document audits per month. Works for Class I, II, and III medical devices including SaMD.

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When users leave MedDeviceAudit reviews, G2 also collects common questions about the day-to-day use of MedDeviceAudit. These questions are then answered by our community of 850k professionals. Submit your question below and join in on the G2 Discussion.

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