RND Group, a Gener8 Company

The RND Group builds and validates software for FDA-regulated medical devices — both Software as a Medical Device (SaMD) and embedded instrument software (SiMD) — with deep roots in in vitro diagnostics and connected instruments and capabilities that extend across med tech and digital health. Founded in 1997 and now the software division of Gener8, we've spent 25+ years shipping regulated device software.

Why teams choose us:

• Instruments and diagnostics are our specialty. Our core is software for FDA-regulated instruments and in vitro diagnostics — and that expertise carries across med tech and digital health, from embedded firmware (SiMD) to Software as a Medical Device (SaMD).
• FDA-ready, and secure. We assess your FDA readiness, build the submission documentation a reviewer expects, and deliver the cybersecurity FDA Section 524B now requires — threat models, SBOMs, and secure design engineered into the product.
• The entire device, under one roof. With Gener8 we go beyond software to the instrument itself — mechanical, electronics, microfluidics, cartridges, and consumables — so one partner takes you end to end, from code to a complete, manufacturable device.

We work to IEC 62304 (including Class B and Class C), ISO 13485, ISO 14971, and 21 CFR Part 820.30 / QMSR, across 510(k), De Novo, and PMA pathways.

Services:

• Custom medical device software development (instrument control, embedded firmware, SaMD, UI)
• FDA readiness assessments
• Cybersecurity & SBOM (FDA Section 524B)
• Verification & validation
• AI/ML in medical devices (GMLP, PCCP)
• QMSR & software quality system remediation
• Cloud & connected devices (MDDS, HL7/LIS integration)

Products: the Application Accelerator (a regulated-app framework), the LIS Connector (HL7/ASTM/POCT1-A connectivity), and the Device Portal (fleet management).

Bring us your device and where it is in its lifecycle — you'll talk to a senior engineer, not a salesperson.