MedDeviceAudit Reviews & Product Details

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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MedDeviceAudit

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Narasimha K.

President and CEO (Owner)

Small-Business (50 or fewer emp.)

5/7/2026

Business partner of the seller or seller's competitor, not included in G2 scores.

"Cuts compliance audit prep from days to minutes"

5/5

What do you like best about MedDeviceAudit?

MedDeviceAudit saves hours of manual cross-referencing. The Evidence Engine maps every finding directly to specific FDA QMSR 2026, ISO 13485:2016, IEC 62304, and ISO 14971 clauses — no guesswork. The SHA-256 evidence anchors give audit-ready traceability, and the zero data retention policy means sensitive technical files are never stored. For regulatory affairs teams under deadline pressure, getting a structured audit report in minutes instead of weeks is a genuine game changer. Review collected by and hosted on G2.com.

What do you dislike about MedDeviceAudit?

As an early-stage product, the platform currently supports document upload audits but does not yet offer real-time collaborative workflows or multi-user team access. A dashboard for tracking audit history across projects would also be a useful addition. These are roadmap items, and the core audit engine already delivers strong value — but enterprise teams managing multiple device files simultaneously will want to watch for these features. Review collected by and hosted on G2.com.

What problems is MedDeviceAudit solving and how is that benefiting you?

Preparing medical device technical files for regulatory audit is one of the most resource-intensive steps in the compliance lifecycle. It requires deep knowledge of multiple overlapping standards and significant manual effort. MedDeviceAudit compresses that process from days to minutes by automating clause-level gap analysis across FDA QMSR 2026, ISO 13485:2016, IEC 62304, and ISO 14971. For small and mid-size medical device companies without large RA teams, this levels the playing field — delivering enterprise-grade audit readiness at a fraction of the cost and time. Review collected by and hosted on G2.com.

Jim L.

Digital Marketing Director

Small-Business (50 or fewer emp.)

5/8/2026

"Rigorous Medial Device Regulatory Auditing without the IP Footprint"

5/5

What do you like best about MedDeviceAudit?

The standout feature for us is the stateless architecture. In the medical device world, uploading sensitive technical files to a cloud-based AI is usually a non-starter for legal reasons, but MedDeviceAudit’s zero-retention policy changes that. I really appreciate that our files are processed only in volatile memory and purged immediately after the report is generated. Knowing our data isn’t being used to train a model or left sitting in a database somewhere gives us the confidence to use AI for high-stakes regulatory work without compromising our trade secrets. Review collected by and hosted on G2.com.

What do you dislike about MedDeviceAudit?

The 9P/2G engine is extremely rigorous. If your initial document is poorly formatted or lacks specific technical context, it flags that immediately and gives you a “harsh” gap assessment. It won’t let you slide on vague language, which is great for compliance, but it can also be a bit of a reality check for the team. I also hope to see more native integrations with PLM systems in the future so we don’t have to manually upload PDFs, although I understand that might conflict with their current “stateless” security model. Review collected by and hosted on G2.com.

What problems is MedDeviceAudit solving and how is that benefiting you?

The biggest problem MedDeviceAudit solved for us was the uncertainty around the FDA’s transition to QMSR and the loss of the safe harbor for internal audits. We needed a way to clean up our internal documentation and make sure it was truly inspection-ready for the 2026 standard, without creating a permanent paper trail of unrefined drafts along the way. With the platform’s stateless architecture, we can audit our files, tighten and remediate the language, and then download the final reports without our IP ever being stored externally. For us, it strikes the right balance between rigorous regulatory compliance and complete data sovereignty. Review collected by and hosted on G2.com.