Compliance challenges

Compliance: a challenge or an opportunity?

Developing software for medical devices isn’t just about coding—it’s about making sure everything runs safely, reliably, and meets strict regulations. With evolving rules like the eu’s medical device regulation (mdr) and standards such as iec 62304, navigating compliance can feel overwhelming. At zentis medical, we don’t see regulations as roadblocks but as an essential part of creating high-quality medical devices.

Why compliance matters

Regulatory standards exist for a simple but critical reason: patient safety. Following them ensures that medical software functions as intended, minimizing risks. But meeting these requirements isn’t always easy. Here are some common challenges:

• documentation overload: every update needs thorough documentation to pass audits.

• third-party software risks: many medical devices rely on external software components (also known as software of unknown provenance, or soup) that weren’t originally made for medical use, leading to extra compliance challenges.

• constant monitoring: compliance doesn’t stop when a device hits the market. security updates, bug fixes, and performance improvements all need to be managed while staying within regulations.

How zentis medical tackles compliance

Compliance isn’t an afterthought for us—it’s built into our development process from day one. We follow strict standards, including:

• IEC 62304: ensuring medical software is designed, tested, and maintained according to best practices.

• risk management: identifying potential problems early and creating solutions to prevent them.

• traceability & documentation: tracking every line of code, every decision, and every test to make sure our software meets the highest standards.

Making compliance work: the eva respiration device

Agreat example of compliance in action is our work on the eva respiration device. This ventilator, designed for emergency respiratory care, had to meet IEC 62304 and strict safety requirements. Zentis medical played a key role in ensuring that the software was not only compliant but also practical and easy to use in high-pressure situations.

Compliance as a competitive advantage

Compliance isn’t just about following rules—it’s about building safer, more reliable medical devices. By embedding regulatory requirements into our workflow, we create software that’s not only compliant but also adaptable to future changes.

Regulations will continue to evolve, and so will medical technology. at Zentis medical, we’re ready to meet those challenges head-on.