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 Device Portal let me do?
“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.”
在公司資料中查看How is it deployed?
“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.”
在公司資料中查看How is a connected fleet kept secure?
“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).”
在公司資料中查看