Services · Teams building a new device or replacing software that won't survive review
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. When the software does not work, the device does not work; we make it work, and make sure you can prove it.
Start a custom development conversation
From algorithm to cleared product
Teams come to us with a device concept, a biomedical algorithm, or a prototype that has to become regulated software. We translate the algorithm into testable code, build the instrument control and operator interface around it, and verify the result against its requirements, so the software is correct, and the evidence that it is correct lands in your design history file. Where it fits, we start from our Application Accelerator, a verification-ready instrument software foundation, which takes roughly six months off the front of a program.
What we build
- Instruments and analyzers, control software, motion and fluidics sequencing, data reduction.
- Embedded and firmware, device controllers and their operating-system support tail.
- Software as a Medical Device (SaMD), standalone diagnostic and analytical software.
- Operator interfaces, touch-screen UIs engineered to IEC 62366 usability.
- Connectivity, LIS and HL7 integration, cloud, and IoT.
Agile inside an IEC 62304 lifecycle
Iterative development and regulated development are not in conflict, if the lifecycle is set up for it. We work in short cycles with regular demonstrations and status reporting, while requirements, risk (ISO 14971), and verification evidence are maintained continuously. You get the responsiveness of Agile and a submission-ready record at the end, not a documentation scramble before you file.
Compliant by design: our Agile development is compliant with IEC 62304, AAMI TIR45, ISO 14971, and FD&C Act §524B, inside an ISO 13485:2016 quality system, and aligned to the FDA QMSR (21 CFR Part 820), EU MDR, GDPR, and HIPAA.
Independent verification, built in
Development and verification & validation are separate teams under one ISO 13485 quality system. The people who verify your software are not the people who wrote it, so the evidence in your submission is independent, which is what a reviewer is looking for.
- 100+
- 100+ applications delivered over 25+ years
- 25+
- 25+ years in business
- 15+ yrs
- Engineers average 15+ years of experience
- ~6 months
- Application Accelerator saves ~6 months versus building a regulated app framework from scratch
One partner, end to end
Software built alongside the instrument.
RND writes and verifies the software. Gener8 designs and manufactures the instrument, cartridges, and consumables around it, mechanical, electronics, optics, and microfluidics, under one roof. Software, device, and disposables from a single partner.
Explore Gener8 capabilitiesFrequently asked questions
- Do you work in Agile, or a phased lifecycle?
- Both, and inside an IEC 62304 software lifecycle either way. We run iterative, Agile development while maintaining design controls, risk management, and requirements traceability throughout, so moving fast never costs you the design history file a submission depends on.
- Can you take over software another vendor started?
- Yes. We assess the existing code and documentation against 21 CFR Part 820.30 and IEC 62304, tell you plainly where it stands, and either continue it or rebuild the parts that will not survive review, with a scope and schedule agreed up front.
- Do you handle the user interface and usability engineering?
- Yes. We design touch-screen instrument interfaces to IEC 62366 usability engineering, aligned with CLIA where the operator is lab staff. On a diagnostic instrument the interface is part of the regulated record, so it is engineered and verified, not bolted on.
- What kinds of device software have you built?
- More than 100 applications over 25+ years, instrument and analyzer control, in vitro diagnostics, Software as a Medical Device, connected and cloud devices, and embedded firmware.
Last reviewed .