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Medical device software testing tools
for accelerated quality and compliance

Medical Device Software that Meets Industry Standards

In the ever-evolving landscape of healthcare, software is playing an increasingly crucial role in the operation and functionality of medical devices. As these devices become more complex and enable groundbreaking bio-science advances to reach the healthcare market, the importance of software within the medical device industry cannot be overstated. The costs associated with software failure, including delays in regulatory approvals, damage to brand reputation, legal disputes, and, most critically, the potential for loss of life, have prompted industry leaders to prioritize the enhancement of safety-critical software quality. Moreover, the growing adoption of international standards has further accelerated this focus on quality.

This pursuit of excellence in software quality aligns with medical device standards, such as IEC 62304, which delineates life cycle requirements for medical software and software embedded within medical devices. IEC 62304 also underscores the importance of adhering to coding standards like MISRA and CERT. In this context, it becomes evident that the pursuit of uncompromising software quality is not just a business priority; it’s a matter of patient safety and industry compliance.

Medical Device Standards

The IEC 62304 standard is crucial for managing software in medical devices, ensuring regulatory compliance, risk mitigation, and global acceptance. MISRA C/C++ coding standards enhance safety, reliability, and compliance, making maintenance easier. CERT C/C++ standards focus on secure coding to reduce vulnerabilities and enhance patient safety, meeting regulatory requirements. These standards are essential in the medical device industry, guaranteeing software quality, safety, and security, benefiting patients and manufacturers.

IEC 62304

Medical device software – software life cycle processes


Guidelines for the use of the C/C++ languages in critical systems


Secure Coding Standard

QA Systems Testing Tools

QA Systems enables organisations to accelerate safety standards compliance with automated static analysis and software testing tools.

“Cantata was easier to setup than the other tools and was more feature complete. No other tool seemed to have the wrapping feature.”

Leon Solinger, Lead Developer for the EarSensor project, FastFocus

“We optimized our code, eliminated unnecessary code, and re-factored parts of the application to make them more efficient. We confirmed great confidence in our software as everything had been tested to 100% decision coverage.”

Rolf Keller, Software Engineer, Hamilton Medical

“Since then it’s been straightforward to maintain the unit tests and create new ones... Cantata is now an integral part of our development process.”

Jim Thomas, Software Development Director, Creo Medical

“Cantata has a lot of powerful features. It was shown to work well with both manually and automatically generated source code.”

Jutta Luosta, Leading Test Developer, GE Healthcare