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This skill acts as a senior consultant for medical device development, providing expert guidance on ISO 14971 implementation. It automates hazard identification, risk evaluation, and the creation of comprehensive risk management files, ensuring compliance with international standards like IEC 62304 for software and FDA cybersecurity guidelines. It is an essential tool for engineering and QA teams needing to integrate safety-by-design, verify risk controls, and maintain rigorous documentation for regulatory submissions such as FDA 510(k) or EU MDR.
