The RND Group
The RND Group: “RND, a Gener8 company. Medical device software engineering for FDA-regulated devices: Software as a Medical Device (SaMD) and embedded instrument software (SiMD), for in vitro diagnostics and connected instruments. Custom development, IEC 62304 verification and validation, FDA readiness, and cybersecurity with SBOM, under an ISO 13485 quality system.”
What does the Application Accelerator actually give me?
“The foundational software a regulated application needs before you write a line of your own logic, a modern UI shell, reporting, logging and audit trails, error handling, user management, and a database abstraction layer, already implemented, tested, and documented. You build your device-specific workflow and algorithms on top of it.”
在公司资料中查看Is it a real, maintained product or a one-off template?
“It is a real, actively maintained C# codebase, updated on an ongoing basis and deployed in commercial products that have launched. You get source or binary depending on your needs, along with the requirements, design, and verification test suite.”
在公司资料中查看Does using it lock me into RND?
“No. It is delivered with documentation and a verification test suite so it fits into your own design history file and quality system. You can license it in binary or source form depending on the product and your needs.”
在公司资料中查看