Molecular diagnostics
Meridian Bioscience (Revogene)
The instrument software raised no FDA concerns during review, across every 510(k) for the platform.
The problem
Meridian Bioscience needed instrument software for the Revogene molecular diagnostics system that could clear FDA review across a growing menu of assays, without the software becoming the reason a submission stalled.
Our approach
RND developed and independently verified the Revogene software under a single ISO 13485 quality system, with development and V&V handled by separate teams, the software lifecycle managed to IEC 62304, and risk managed to ISO 14971. Design controls were documented to 21 CFR Part 820.30 for each 510(k).
The outcome
The software raised no FDA concerns during review, across every 510(k) submitted for the Revogene platform. Keeping development and verification in separate teams under one quality system meant every submission arrived with independent evidence that the software met its requirements, not a self-review.
Narrative is a working draft pending review with the project team; the cleared-assay outcome is an approved public claim.