Cybersecurity-Centric Medical Device Firmware Development: The Role of IEC 62304 and Embedded Real-Time Operating Systems (RTOS) in Ensuring Safety and Compliance

Abstract

This paper presents a comprehensive exploration of cycbersecurity aspects for medical devices developed under IEC 62304 and RTOS frameworks.

When building software for medical devices, security matters a lot. Following IEC 62304 means planning every stage carefully. Because mistakes can harm patients, each update gets reviewed thoroughly. Instead of treating safety and function separately, they work together from start to finish. With threats always changing, checks happen continuously. Even small code changes follow strict rules. So risks drop when design meets real world demands early. Trustworthiness comes first, then meeting legal standards. The process opens with spotting key risks early

One big worry for tiny computers inside medical gear is when bad code sneaks in. Hacking through repeated signals happens too, messing up normal operation. Access without permission opens more doors than it should. These risks change how devices behave in quiet but serious ways. Regular upgrades to device software matter because actual breaches show what happens without strong defenses. This report examines events where weak protection led to serious problems. One example follows another showing how fast threats spread when systems lack updates. Each case reminds us that small gaps invite big risks. Attention to detail grows more critical after seeing repeated failures. What seems minor often becomes major through neglect. Real damage occurs even when warnings were clear beforehand.

Building things comes first. Then keeping them running matters just as much. Staying alert for what could go wrong shapes how work moves forward. That part matters inside worldwide rules like those from the FDA or the EU MDR and ISO standards. The paper evaluates the limitations of bare, metal systems. Yet shows what RTOS setups do when problems appear by locking down timing, keeping errors separate, starting up safely, yet connecting each piece tightly.

One step back reveals how systems hide complex details. FreeRTOS stands out when looking at approval ratings across industries. Zephyr follows close, tied strongly to safety checks built for hospitals. Security steps up differently under QNX, known more for steady performance than flash. Then there is INTEGRITY, fitting niches where rules are strictest. Each year shifts what matters most, 2025 reshapes priorities again

Looking at FDA cybersecurity advice shows what it means for, One part involves firmware setup, along with checking possible risks. Another piece tracks what components are used, making sure records stay up to date. Keeping updates safe while managing risks in how products are delivered.

Next up, ways to weave cybersecurity into RTOS work that follows IEC 62304 are laid out in the report. Writing code that stays safe. Making real, time operating systems tougher against threats. Fixing known issues regularly through updates. Yet checking methods include things like static or dynamic review, plus trying out security through penetration tests, along with strict proof using formal verification. Examples drawn from real situations show how these work

Folks like Ottobock or Innolitics, then again, actual events show similar patterns. Moments from hospitals, moments from labs, each pointing in one direction without saying it outright. Buzzing machines in hospital rooms can fail when signals twist. Hidden flaws appear through quiet shifts in beeping patterns. Devices meant to protect sometimes open backdoors instead. Weak spots emerge not from design but how pieces connect

Finding new paths matters most. Looking ahead shapes what comes next. Some ideas point toward tomorrow. What follows builds on earlier steps. Thoughts turn to what might be. Later sections examine where things could go.

Finding threats using smart tools runs alongside cloud and local systems working together. Security logs live on a shared chain so changes show up fast. Trust nothing by default shapes how access gets managed every step of the way. Virtual copies mirror real devices while testing odd behaviors ahead of time. New math guards data when future computers grow too powerful. Secret codes help lock down device software, making tough protection a key part of next, generation surgical and diagnostic systems.