The RND Group
The RND Group is an Indianapolis-based software engineering firm that builds FDA-regulated software for medical device companies, spanning IVDs, SaMD, and instrument control systems, with a 50-device regulatory track record over 25+ years.
- Company typePrivate
- Founded1997
- HeadquartersIndianapolis, United States
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What The RND Group does
The RND Group (operating as 'gener8 | The RND Group' following its December 2021 acquisition by Gener8) is an Indianapolis-based software engineering firm that builds FDA-regulated software for medical device companies. Its portfolio spans custom development, cloud solutions, LIS integration (HL7 v2.5/v2.6/v2.7, ASTM 1394/1381, POCT1-A), IoT device fleet management, cybersecurity, and software verification and validation. The company has shipped 50+ FDA-approved devices over 25+ years and holds quality systems aligned to IEC 62304 and ISO 13485, with named case-study customers across molecular diagnostics (NeuMoDx, Meridian Bioscience, Rheonix), dental technology (Convergent Dental), food safety (InstantLabs), genomics (Illumina MiSeqDx integrations), and cardiac monitoring.
The company operates four productized offerings — FDA Readiness Assessment, Application Accelerator, LIS Connector, and Device Portal — layered on top of project-based professional services. The Application Accelerator is a reusable framework that compresses build time for new programs, while the Device Portal is positioned as a cloud-based, multi-tenant solution that reduces the need for field service visits. Revenue derives primarily from custom software development engagements with enterprise medical device OEMs; productized services and subscriptions represent a secondary, growing layer. Distribution is direct enterprise sales augmented by content marketing (case studies, white papers, blog), trade-show presence, and a free consultation entry point. The company has a strategic partnership with Hamilton (preferred software partner for STAR liquid handling integrations) and a co-development relationship with KeyTech.
The RND Group firmographics
Firmographics- Name
- The RND Group
- Legal name
- The RND Group
- Website
- https://rndgroup.com
- Company type
- Private
- Founded year
- 1997
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- The RND Group is an Indianapolis-based software engineering firm that builds FDA-regulated software for medical device companies, spanning IVDs, SaMD, and instrument control systems, with a 50-device regulatory track record over 25+ years.
- Ownership category
- akta.pro rank
The RND Group industry classification
Industry- Product category
- Medical Device Software Development
- NAICS
- Custom Computer Programming Services (541511), Software Publishers (5132)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)
- akta.pro secondary industries
- Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN), SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)
Keywords
Where The RND Group is headquartered
LocationHeadquarters
- HQ city
- Indianapolis
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
The RND Group business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- Custom Software Development Services: Full lifecycle software development services for medical device companies including requirements definition, software design, implementation, verification, and deployment. Revenue is generated through project-based engagements with FDA-regulated medical device companies.
- Packaged Software Products: Pre-built solutions including FDA Readiness Assessment, Application Accelerator, LIS Connector, and Device Portal offered as productized services to medical device companies
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Free Consultation |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
The RND Group product offering
Product offeringCore offering
The RND Group writes FDA-regulated custom software for medical devices, including in vitro diagnostic products (IVDs) and Software as a Medical Device (SaMD). The company provides end-to-end software development services from requirements through deployment, complemented by productized offerings: FDA Readiness Assessment (independent regulatory assessment prior to FDA submission), Application Accelerator (reusable software architecture framework), LIS Connector (HL7/ASTM/POCT1-A connectivity to LIS and EHR systems), and Device Portal (cloud-based instrument management).
Product overview
The RND Group is a medical device software development company that provides custom FDA-ready software solutions for medical devices, including in vitro diagnostic products (IVDs) and Software as a Medical Device (SaMD). The company's offerings consist of four core products: FDA Readiness Assessment (a packaged service for independent regulatory assessment), Application Accelerator (a proven software architecture framework for jump-starting development), LIS Connector (for laboratory and EHR system connectivity supporting HL7 and ASTM protocols), and Device Portal (a cloud-based instrument management solution). The portfolio is complemented by professional services including custom development, cloud solutions, technical assessment, cybersecurity, and software verification and validation.
Differentiator
Problem solved
Functional benefit
Brands
- gener8: A full-service engineering and guide for biotech innovators along the path to market, offering end-to-end process and integrated solutions including instrument development, manufacturing, and microfluidic cartridge development.
Products and services
- FDA Readiness Assessment A packaged service that provides an independent assessment of a medical device software product prior to submitting it for FDA approval, aimed at medical device manufacturers preparing for regulatory submission.
- Application Accelerator A proven software architecture and framework of reusable services used to jump-start the development of custom FDA-regulated software solutions for medical device companies.
- LIS Connector A pre-built integration software product that provides immediate connectivity between medical device software and Laboratory Information Systems (LIS) or Electronic Health Record (EHR) systems, supporting HL7 v2.5/v2.6/v2.7, ASTM 1394/1381, and POCT1-A protocols, with customization available for customer-specific needs.
- Device Portal A secure, cloud-based multi-tenant application for managing deployed medical device instruments via the web browser, including instrument health monitoring, software updates, organizational management, and reporting, eliminating the need to dispatch field service personnel.
- Custom Medical Device Software Development Full lifecycle custom software development services for FDA-regulated medical devices, covering requirements definition, software design, implementation, verification, validation, and deployment for IVDs, SaMD, and other FDA-regulated medical device projects.
- Cloud Solutions for Medical Devices Cloud-based development services for medical devices, including IoT implementations, cloud Medical Device Data Systems (MDDS), cloud-native instrument management, and HIPAA-compliant processing for medical device fleets.
- LIS Integration Services Professional services to integrate medical device software with Laboratory Information Systems (LIS) and Electronic Health Record (EHR) systems, leveraging the LIS Connector product and supporting HL7 v2.5/v2.6/v2.7, ASTM 1394/1381, and POCT1-A protocols.
- Technical Assessment Services Independent technical assessment services for medical device software, including acquisition assessment and GAP analysis on software development documentation for regulatory and quality purposes.
- Cybersecurity Services for Medical Devices Cybersecurity services tailored to FDA-regulated medical devices, including security design, vulnerability assessment, and alignment with regulatory cybersecurity requirements for medical device software.
- Software Verification and Validation Services Software verification and validation services aligned with IEC 62304 and FDA expectations, covering test planning, execution, traceability, and documentation required for medical device software regulatory submissions.
- Quality System Compliance Assessment Quality system compliance assessment services for medical device software manufacturers, aligned with ISO 13485 and IEC 62304, designed to identify gaps and prepare organizations for FDA and regulatory audits.
Companies that use The RND Group
Customer profileNamed customers10 records
Segments2 records
Ideal customer profiles2 records
The RND Group technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
The RND Group partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- HamiltoncoreRND Group is one of Hamilton's primary software development partners recommended to OEM customers. RND has extensive experience in Hamilton STAR liquid handling system integration, which was incorporated into NeuMoDx instrument development. This partnership provides RND with preferred access to medical device companies seeking Hamilton integration expertise.
- KeyTechcoreKeyTech, a product development partner, referred InstantLabs to RND Group for software development. RND also worked with KeyTech and Rheonix on the Encompass workstation development. KeyTech provides mechanical and usability engineering services while RND provides software development expertise.
- Centers for Disease Control and Prevention (CDC)minorCDC receives daily feed of infectious disease reporting data from cloud solution developed by RND Group for client. This demonstrates RND's ability to develop solutions meeting public health organization requirements.
- Gener8coreGener8 acquired RND Group in December 2021, expanding into life sciences software development. Gener8 provides instrument development, manufacturing, microfluidic cartridges and plastic consumables development, while RND provides complementary software expertise for FDA-regulated medical devices.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
The RND Group competitors and assessment
Company assessmentDirect peers
- ClariMed: Medical device development services firm combining human factors, regulatory, and software services for med device companies. Directly comparable to RND's FDA-regulated software and quality system offerings for device OEMs.
- NAMSA: Medical device-focused CRO/CDMO offering testing, regulatory, and software-related services. Overlaps with RND in supporting IVD and SaMD clients through FDA submission lifecycles.
- StarFish Medical: Full-service medical device design and engineering firm with embedded software capabilities. Competes with RND for med device OEMs needing turnkey hardware + regulated software development.
- Veranex: Medical device product development and engineering services provider with software, regulatory, and clinical capabilities. Comparable as a one-stop-shop alternative to RND's regulated software services.
- Arbour Group: FDA compliance, validation, and software quality services firm for life sciences and medical devices. Directly competes with RND on validation, QMS, and 21 CFR Part 11 / IEC 62304 services.
Emerging players
- Greenlight Guru: Cloud QMS software purpose-built for medical device companies. Adjacent rather than direct — competes for the same customer's compliance budget but sells SaaS rather than custom services.
Broad incumbents
- MasterControl: Established QMS and quality/compliance software vendor serving life sciences and med device manufacturers. A larger, portfolio incumbent whose customers overlap RND's regulated software install base.
- IQVIA: Global life sciences technology and services giant with med device regulatory and software offerings. Represents the scale competitor RND could be displaced by in enterprise MSAs.
- Synopsys (Silicon to Systems): Provides verification, IP, and software integrity tooling with a medical device vertical. Competes with RND for embedded software verification and validation work on regulated devices.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
The RND Group social profiles
Digital presenceThe RND Group financial estimates
Financial estimateRevenue estimate
Valuation estimate
The RND Group leadership team
Management profileNumber of profiles
Profiles1 record
The RND Group funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
The RND Group M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about The RND Group
What does The RND Group do?
The RND Group writes FDA-regulated custom software for medical devices, including in vitro diagnostic products (IVDs) and Software as a Medical Device (SaMD). The company provides end-to-end software development services from requirements through deployment, complemented by productized offerings: FDA Readiness Assessment (independent regulatory assessment prior to FDA submission), Application Accelerator (reusable software architecture framework), LIS Connector (HL7/ASTM/POCT1-A connectivity to LIS and EHR systems), and Device Portal (cloud-based instrument management).
Is The RND Group a public or private company?
The RND Group is a private company. It is classified as corporate owned and is currently operating.
When was The RND Group founded?
The RND Group was founded in 1997. It employs 51 to 100 people.
Where is The RND Group based?
The RND Group is headquartered in Indianapolis, United States, in the North America region.
How does The RND Group make money?
Two revenue lines are on record. Custom Software Development Services are the primary driver. The others are packaged Software Products.
Who are The RND Group's main competitors?
Direct peers on record are ClariMed, NAMSA, StarFish Medical, Veranex and Arbour Group. Greenlight Guru is listed as an emerging player. Broad incumbents are MasterControl, IQVIA and Synopsys (Silicon to Systems).
Does The RND Group have an API?
No public API is recorded for The RND Group.
What industry is The RND Group in?
The RND Group's product category is Medical Device Software Development. Its primary akta.pro industry code is HLACANAN, DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA), with a secondary code of HLACAOAN, Regulatory Submissions & Clinical Content Management (eCTD/Publishing). Its NAICS code is 541511 and its SIC code is 7372.