Services

Software for FDA-regulated medical devices, built, verified, and taken through review.

RND builds and verifies medical device software with separate development and V&V teams under one ISO 13485-compliant quality system. Whether the software runs on hardware you designed or on an instrument designed by Gener8, our software process has a long track record in FDA submissions. Every engagement, new development or legacy remediation, is scoped to a defined artifact list before work begins, so it stays well managed from start to finish.

Custom Software Development

RND builds medical device software from algorithm to cleared product: instrument control, embedded firmware, Software as a Medical Device, cloud, and the operator interface, engineered to IEC 62304 and 21 CFR Part 820.30 so it holds up under FDA review.

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Software as a Medical Device (SaMD)

When the product is the software itself, a diagnostic algorithm, a clinical decision support tool, a mobile medical app, it is Software as a Medical Device (SaMD), and the full FDA burden lands on the code.

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Cloud & Connectivity

RND builds the cloud and connectivity layer for regulated instruments, medical device data systems, high-throughput telemetry, and remote access, engineered for scale and for the record.

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Quality & Compliance

The software quality system is where medical device software most often stalls.

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Cybersecurity

FDA premarket and postmarket cybersecurity for connected diagnostics and instruments, threat models, SBOM, and the engineering to close the findings.

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Verification & Validation

RND verifies medical device software with a team that is independent of the developers, and supports software validation when a project calls for it.

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AI/ML in Medical Devices

RND builds and verifies AI/ML features in medical device software, Software as a Medical Device and AI-enabled instruments, under the approach FDA now expects: Good Machine Learning Practice, a Predetermined Change Control Plan for models that keep learning, and risk management that treats the model as part of the device from the first design review.

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AI-Assisted Engineering

RND builds AI into its design and development workflow to shorten time to market and lower development cost on regulated medical device software.

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