RND, a Gener8 company, builds and independently verifies the software inside FDA-regulated medical devices — and, together with Gener8, the instruments, microfluidics, and consumables around it. Software, device, and consumable, one partner.
For 25+ years we've delivered software for regulated medical and diagnostic devices to exacting standards — IEC 62304, ISO 13485, ISO 14971, and 21 CFR Part 820 — with separate development and verification & validation (V&V) teams working under one quality system. Our engineers average 15+ years of experience, and our software has never been the reason an FDA submission stalled.
We work across in vitro diagnostics (IVD), point-of-care and molecular diagnostics, immunoassay and clinical analyzers, imaging, and connected/cloud-based devices — including device connectivity to LIS and EHR systems via HL7, FHIR, and ASTM.
What we do
• Custom medical device software development
• Software verification & validation (IEC 62304)
• FDA readiness assessments
• Cybersecurity (FDA §524B)
• AI/ML in medical devices
• QMSR & legacy remediation
Products
• Application Accelerator — a regulated-app framework that saves ~6 months versus building one from scratch
• Device Portal — a secure, cloud-based device management solution
• LIS Connector — immediate connectivity between device software and LIS/EHR systems
Talk to an engineer who has been an through FDA review: www.rndgroup.com
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