Strategy and Solutions
A global medical device OEM producing connected infusion pumps for hospital deployment. The company was preparing a 10,000‑unit rollout and needed to satisfy FDA 510(k) cybersecurity expectations and hospital security reviews.The solution included bedside devices, BLE connectivity, OTA updates, a cloud dashboard, and FHIR integration.
Security testing had been limited, leaving potential issues in firmware, update mechanisms, and cloud communication. Any exploit affecting dosage commands, uptime, or telemetry could impact patient safety and jeopardize large contracts.The OEM required an independent security assessment and a clear remediation plan aligned with regulatory expectations.
With Zymr’s support, the manufacturer:
IoMT Security Assessment
Device and Cloud Hardening
Compliance Support• Aligned documentation and controls with FDA and NIST 800‑213 guidance• Helped respond to hospital security questionnaires with clear evidence of controls
.svg)
.svg)
.svg)
.svg)
.svg)
.svg)