“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.”
“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.”
“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.”
“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.”
“Manage a deployed fleet of instruments from a web browser, monitor instrument health, push software updates and data such as protocols and assays, and pull usage and diagnostic reports for a single instrument or a whole organization. It removes the need to send field-service staff for routine tasks.”
“As a multi-tenant, cloud-hosted application by default, with per-customer organizations, users, and instrument assignments. Other configurations are possible depending on your requirements.”
“Managing instruments over the internet is a cyber-device problem, and we treat it as one. The Portal is built to current medical device cybersecurity expectations, and the deeper work, threat modeling, SBOM, and FDA Section 524B obligations, is covered by our [cybersecurity services](/cybersecurity).”
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