Preparing for the U.S Food and Drug Administration (FDA) premarket and 510(k) submissions
Expanded health access with telemedicine and digital health solutions; personalized healthcare and advanced detection and monitoring for improved patient outcomes. Operational efficiencies through automation, digitalization, and entirely new workflows. Promising cutting-edge Internet of Medical Things (IoMT) and AI-powered solutions tackling today's most challenging issues. For the medical and healthcare industry, technology holds massive untapped potential. Yet, it also comes with novel challenges.
Robust & secure over-the-air updates for medical & healthcare devices
To realize the massive potential of new technology, medical and healthcare device OEMs must embrace modern, purpose-fit infrastructure. Advancing patient outcomes requires innovation, and innovation in a software-centered world requires robust and secure over-the-air (OTA) updates. Without it, innovation and, thereby, progress fail.
Securing healthcare, medical, and Internet of Medical Things (IoMT) devices
The rapid growth of IoMT and escalating cybersecurity threats make it necessary for healthcare and medical OEMs to adopt a medical-grade OTA update strategy. Solutions must both address immediate security concerns while simultaneously accommodating regulations like FDA 501(k) and the NIS2 directive.
Connected medical and diagnostics devices, OTA software updates & device management
For medical IoT devices, manufacturers can use OTA updates and remote access for feature enhancements, remote support, and security.
Medical & diagnostics solution sheet
A solutions sheet outlining the challenges specific to medical & diagnostics IoT devices, and how Mender solves them.