Automated, audit-ready design review for medical device teams
The Challenge
In medical devices, every drawing revision is part of a regulated audit trail, and an escaped error is not a scrapped batch, it is a recall and a patient-safety event. Design controls, ISO 13485, and inspection documentation stack review work on top of checks that are already slow by hand. bananaz automates the comparison, standards enforcement, and inspection documentation that drag review down, so engineers spend their time on judgment, not on catching missed changes.
Benefits for medical devices
Compare every revision automatically.
bananaz puts two revisions side by side and isolates exactly what changed in the geometry and the notes, flagging only what affects form, fit, or function. A view that moved without a real change does not get flagged
.png)
Enforce and automate your standards
bananaz learns your company standards and GD&T conventions, then checks every drawing against them automatically. Violations get flagged in place, so a noncompliant callout is caught in review, not in production.
Automate inspection documentation
Auto-balloon drawings and generate inspection reports in your company format, exported in one click. The tedious manual work of building inspection packages becomes a near-instant step.
Traceability with every release
bananaz syncs with your PDM on check-in and keeps the full version lineage: who changed what, when, and why, captured as you go. The record that supports your design history file assembles itself instead of being reconstructed before an audit.
.avif)
Security and trust
bananaz is built security-first on AWS: isolated VPCs, encryption in transit and at rest, SSO and MFA with role-based least-privilege access, and full audit logging. It maintains a SOC 2 Type II report and CSA STAR Level 1, and the same posture has already cleared enterprise security reviews at large medical device manufacturers.
Full documentation at trust.bananaz.ai.
Change for the Better
Schedule a demo and discover how bananaz can accelerate your product development from concept to delivery
