G2

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.