Part 1: Unlocking the Essentials of IEC62304 for Medical Devices

Learn how SpiraPlan helps you achieve IEC 62304 compliance for medical device software. Visit www.Inflectra.com/SpiraPlan for more!

Inflectra and Inmarsys teamed up to present a webinar series on IEC 62304, the key standard for medical device software development. Part 1 of this series delved into how IEC 62304 ensures compliance, quality, and safety in the highly regulated medical device industry. We demonstrated how SpiraPlan implements the principles of IEC 62304, highlighting the best practices that make this standard crucial for the successful development of medical software.

During the webinar, attendees learned about:

• The fundamentals of IEC 62304: We provided a comprehensive overview of this vital standard and its role in defining the Software Development Life Cycle (SDLC) for medical devices.
• The importance of compliance: We explored why adhering to IEC 62304 is essential for bringing medical devices to market, emphasizing its harmonization with major regulations and recognition by global authorities like the FDA.
• Key principles for success: We uncovered the core principles of successful medical software development under IEC 62304, including requirement gathering, risk management, design, and traceability.
• The SDLC process: We offered a high-level overview of the Software Development Life Cycle process as defined by IEC 62304.

The webinar concluded with an interactive Q&A session where attendees had the opportunity to engage with industry experts and gain further insights into IEC 62304 and its practical applications.