Achieve medical device regulatory compliance

Software plays a pivotal role in today's medical device landscape. Ensuring its safety and effectiveness while meeting rigorous regulatory standards demands precision and expertise. Our white paper provides invaluable insights into this complex challenge.

Navigate the complexities of medical device compliance

The IEC 62304 standard defines the roadmap for medical device software, emphasizing requirements management, architecture, systems design and rigorous testing. A robust risk management system is integral to the process, as ISO 14971 sets the foundation for managing risk aspects. However, the challenges arise when changes to the software occur post-production. A critical analysis by the FDA revealed that a staggering 79% of medical device software recalls were due to software defects introduced after initial distribution. These pitfalls underscore the importance of consistent quality and validation guidelines throughout the entire product lifecycle.

Achieve IEC 62304 and FDA compliance for medical device software

Managing the intricacies of IEC 62304 and FDA compliance can be daunting, but our comprehensive solution, Polarion, simplifies the process. Discover how Polarion empowers you with industry-proven processes, secure workflows, intuitive traceability features and advanced analytics. It's the key to developing high-quality medical solutions while meeting the most stringent standards.

Download the white paper to learn more.