About
About The RND Group
The RND Group is a medical device software engineering firm that builds and verifies software for FDA-regulated devices, for in vitro diagnostic and instrument companies whose software has to hold up in an FDA submission. RND, a Gener8 company, has worked in Indianapolis since 1997.
Last reviewed October 1, 2026
What The RND Group does
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.
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. RND builds SaMD to IEC 62304, ISO 14971, and IEC 62366 usability, with the cybersecurity and submission evidence review expects.
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. Separating V&V from software development gives an honest assessment of the work, while doing both inside one ISO 13485-compliant quality management system keeps the work efficient and the teams in close communication.
Quality & Compliance
The software quality system is where medical device software most often stalls. RND builds the software spine of your quality system, the IEC 62304, ISO 14971, and 21 CFR Part 820.30 procedures and records software needs, remediates the gaps QMSR exposed, and tells you exactly where your software and its documentation stand before you file.
Cybersecurity
FDA premarket and postmarket cybersecurity for connected diagnostics and instruments that meet the Section 524B cyber device definition: threat models, SBOM, security testing, and the engineering to close the findings.
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. We took Holter processing from hours to under ten minutes, and we run a cloud platform feeding a daily infectious-disease data feed to the CDC.
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.
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. Every AI-assisted artifact, and the IEC 62304 and 21 CFR Part 11 records behind it, is reviewed by a seasoned engineer, traced into the design history file, and verified by our independent V&V team, so the quality and design-control rigor of an FDA submission stay intact.
Products
Application Accelerator
The Application Accelerator is a comprehensive, cross-platform software framework for regulated medical device applications, with an established verification pathway. The user interface, reporting, logging and auditing, error and user management, and database layer already exist; we adapt them to your device while your team focuses on its workflow and algorithms, for roughly a six-month head start over building the framework from scratch.
LIS Connector
The LIS Connector gives a medical device immediate connectivity to laboratory information systems and EHRs, HL7 v2.5/2.6/2.7, ASTM 1394/1381, and POCT1-A over TCP/IP, serial, or file, so you skip months of building and verifying a custom integration. It ships as a library or a server, on Windows or Linux, with the requirements, design, and verification test suite you need for your own submission.
Device Portal
The Device Portal provides remote monitoring, fleet visibility, and secure update management for instruments in the field. It is a cloud-hosted web application for pushing software updates, monitoring instrument health, and pulling usage and diagnostic reports, so routine field work no longer means sending someone on site.
What makes The RND Group different
Independent V&V under one quality system
Separate development and V&V teams under one quality system. Developers never verify their own code, which gives an honest assessment of the work, while a shared ISO 13485-compliant system keeps the two teams efficient and in close communication. Many software vendors test their own work, or leave V&V to the client.
Software and instrument under one roof
Through Gener8, the same partner can design and manufacture the instrument, microfluidic cartridges, and consumables the software runs on. Hardware and software decisions get made together instead of across two vendors.
Deep in vitro diagnostics experience
RND's work centers on diagnostic instruments and the laboratory systems around them. On NeuMoDx, that meant instrument software for a system that runs 288 samples at once, cleared through 510(k), EUA, and CE-IVD. On Revogene, the software raised no FDA concerns during review.
A head start from an established framework
The Application Accelerator gives new instrument software an established foundation with a proven verification pathway, adapted to your device. That saves ~6 months over building a regulated application framework from scratch.
Senior engineers with long tenure
Engineers average 15+ years of experience, and RND has 25+ years in business. The people on your project have taken regulated software through FDA review before.
Who uses The RND Group
- Medical device companies preparing their first software submission (510(k) or De Novo)
- Diagnostics companies moving an instrument from research use only (RUO) to a cleared IVD
- Investors and acquirers doing software diligence on a medical device company
- Device teams that have lost confidence in their current software vendor
- Instrument makers adding LIS connectivity, cloud features, or cybersecurity to a device already on the market
The team behind The RND Group
Tim DeFrench founded RND in Indianapolis in 1997 to build software for FDA-regulated medical devices, and the company has done that work for more than 25 years. In December 2021, Gener8 acquired RND, bringing software together with instrument, cartridge, and consumable engineering under one roof. Today RND runs separate development and V&V teams with US-based engineers, and was named one of the Best Places to Work in Indiana (2021).
Our engineers average 15+ yrs building software for regulated medical devices, and the people who take your project through review are the people who did the same on the diagnostics platforms above.
Follow RND on LinkedIn, or see careers at RND.
How The RND Group works
Two ways to engage
RND can run the full software program, or put specialists alongside your own engineers, whether that is V&V, cybersecurity, or an FDA software-readiness assessment. Most engagements are collaborative, with your team involved throughout.
It starts with your device
The first conversation is with a senior medical device software expert who reviews your device and where it sits in its lifecycle. From there, the work is scoped to a defined artifact list before anything begins.
One lifecycle, start to finish
Work runs inside the IEC 62304 lifecycle and ISO 14971 risk process, with requirements, design, code, and tests traced into the design history file as the project goes, so the submission evidence is produced by the work instead of assembled at the end.
AI-assisted, human-reviewed
RND uses AI to speed up first drafts of requirements, code, tests, and documentation. A seasoned engineer reviews every AI-assisted artifact, and the independent V&V team verifies the result. How we use AI
Key facts about The RND Group
- Company name
- The RND Group (RND, a Gener8 company)
- Type
- Medical device software engineering firm
- Founded
- 1997, in Indianapolis
- Founder
- Tim DeFrench
- Headquarters
- Indianapolis, Indiana, USA, with US-based teams nationwide
- Parent organization
- Gener8 (instrument, cartridge, and consumable design and manufacturing), backed by Sverica Capital Management
- Acquired
- By Gener8 on December 9, 2021
- Website
- rndgroup.com
- Core offering
- Software for FDA-regulated medical devices: Software as a Medical Device (SaMD) and embedded instrument software (SiMD), with independent verification
- Services
- Custom Software Development, Software as a Medical Device (SaMD), Verification & Validation, Quality & Compliance, Cybersecurity, Cloud & Connectivity, AI/ML in Medical Devices, AI-Assisted Engineering
- Products
- Application Accelerator, LIS Connector, Device Portal
- Quality system
- ISO 13485-compliant, to the IEC 62304 software lifecycle and ISO 14971 risk management
- Engagement models
- Full program team, or specialists working alongside your engineers
- Notable clients
- NeuMoDx Molecular, Meridian Bioscience (Revogene), Rheonix, Convergent Dental, InstantLabs, Conservation X Labs
- Applications delivered
- 100+ applications delivered over 25+ years
- Engineering experience
- Engineers average 15+ years of experience
- Social