The RND Group | a gener8 company is a specialized software engineering firm focused on developing custom FDA-regulated software for medical devices. Now part of Gener8, The RND Group also offers development and manufacturing services for medical devices and consumables, expanding their capabilities beyond software into hardware and product realization.
The company is known for building high-quality, regulated software tailored for the medical device industry, addressing requirements for precision, compliance, and interoperability. Their offerings include:
- Custom software engineering for medical devices and FDA-regulated industries
- Cross-platform solutions with their Application Accelerator
- FDA readiness assessments
- Device Portal: a secure, cloud-based management solution
- LIS Connector: enabling connectivity between medical device software and LIS/EHR systems
- Full project lifecycle development, requirements management, project management, and software verification
With over 20 years of experience, The RND Group has established itself as a reliable partner for companies needing specialized software in areas such as molecular diagnostics, immunoassay analyzers, clinical diagnostics, device connectivity, and in vitro diagnostics. Their team is structured to deliver projects with rigorous attention to compliance, quality, and performance.
How was The RND Group | a gener8 company started?
The RND Group was founded by a team of experienced software and quality professionals, including Stephanne Flint (Vice President of Software), Brad Graves (Director of Software), Matt Verner (Director of Software), Chris Gray (Director of Software), and Nathan Plant (Senior Manager, Quality & Compliance). With backgrounds spanning software development, IT infrastructure, and medical device quality engineering, the leadership team brings decades of expertise in regulated environments and risk management.
Who uses The RND Group | a gener8 company?
The RND Group primarily serves medical device manufacturers and companies operating in the highly regulated healthcare technology sector. Their services are aimed at organizations requiring custom, reliable, and compliant software solutions for devices that must meet FDA and other regulatory standards. While specific customer names are not listed, their expertise is relevant to diagnostics companies, clinical laboratories, and healthcare technology providers.
What makes The RND Group | a gener8 company different?
The RND Group distinguishes itself with deep domain expertise in FDA-regulated software and a refined development process honed over two decades. Their ability to deliver turnkey solutions, from requirements development through verification, along with proprietary tools like the Application Accelerator and Device Portal, positions them as a comprehensive partner for medical software engineering and device connectivity.
You can learn more about their history and leadership on their About page.
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