Case Study: Leading Infusion Pump Manufacturer achieves FDA 510(k) cybersecurity clearance with Zymr's secure IoMT platform

a leading infusion pump manufacturer passes FDA 510(k) cybersecurity pre-submission with zero findings using Zymr

The client, a leading infusion pump manufacturer, faced significant challenges in meeting stringent FDA cybersecurity requirements for its connected medical devices ahead of a large-scale deployment. Their existing architecture lacked standardized security controls, creating compliance and patient safety risks. To address this, the organization partnered with vendor Zymr to design and implement a secure and compliant Internet of Medical Things (IoMT) platform.

Zymr implemented a comprehensive IoMT solution aligned with FDA and NIST guidelines. This included a secure gateway architecture, BLE for over-the-air firmware updates, and advanced security mechanisms like secure boot and encryption. As a result, the client passed their FDA 510(k) pre-submission audit with zero findings, resolved 19 security vulnerabilities, and enabled the secure nationwide deployment of 10,000 infusion pump units, significantly accelerating their time-to-market.