Understanding IEC 62304 in Medical Device Software Development

The International Electrotechnical Commission (IEC) 62304 standard outlines the requirements for the development, maintenance, and lifecycle management of software used in medical devices. Adhering to IEC 62304 is critical for medical device developers to ensure that their products meet safety and performance standards. The blog explains the risk-based approach to software development and the need for a comprehensive software roadmap to ensure durability, functionality, and compliance. The guidelines for utilizing IEC 62304 in medical device development are also discussed, emphasizing the importance of practicing due diligence to maintain the highest level of compliance with safety standards.

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Purva Shah

Purva Shah works as Assistant Product Marketing Manager and focuses on the Digital technology landscape - Cloud, AI/ML, Automation, IoT, Edge Services, Legacy Modernization, Quality Assurance, Mobility, and Application Modernization. She carries 6+ years of experience in Product Positioning, Practice Marketing, Go-To-Market Strategies, and Solution Consulting.

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