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Enhancing Medical Device Software Quality - Part 1

In medical device development, software reliability and safety are non-negotiable because of the critical role these devices play in patient care. Static Code Analysis and Architecture Verification are vital practices that ensure high-quality, dependable software.Static Code Analysis examines code without execution, detecting errors, bugs, and security vulnerabilities early. Architecture Verification confirms that the software’s structure aligns with design specifications, ensuring components function as intended. These practices mitigate risks of malfunctions, which could have severe consequences, while enhancing security and reducing costly rework. These techniques are essential for compliance with rigorous standards and regulations in the medical device industry, ensuring regulatory approval and market readiness by demonstrating systematic risk management and quality control. When considering the medical device development workflow, these practices are strategically timed. Roger Mazzella, Global Medical Industry Leader and Aaron LaBomascus, Senior Solutions Engineer will explore the importance of Architecture Verification and Static Code Analysis, supported standards, and optimal integration, offering practical insights for enhancing medical device software safety and compliance.

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