medical-device-software-compliance

IEC 62304 safety classification requires evaluating potential harm to patients and users. This skill provides expert reasoning frameworks to classify your Software as a Medical Device accurately, mapping the classification to necessary lifecycle documentation and design controls required for compliance.

The regulatory pathway for an AI-based diagnostic tool depends on its risk profile and intended use. This skill guides you through FDA 510(k), De Novo, PMA, and EU MDR compliance requirements, helping you determine the correct submission strategy and necessary documentation.

Generating a compliant traceability matrix involves linking software requirements, design specifications, risk controls, and verification activities. This skill maps your software development phases to 21 CFR 820.30 design controls and IEC 62304 standards to ensure formal traceability throughout the lifecycle.

Assessing SOUP risk involves identifying anomalies, hazards, and cybersecurity vulnerabilities in third-party components. This skill supports ISO 14971 risk management by providing decision frameworks to evaluate third-party software components and integrate them safely into your medical device system.

Yes, this skill maps software development phases directly to 21 CFR 820.30 and IEC 62304 lifecycle requirements. It provides structured reasoning to ensure your design inputs, outputs, reviews, and validation activities satisfy formal regulatory documentation standards.

Yes, this skill satisfies requirements for cybersecurity assessment in medical software development. It provides expert reasoning to evaluate security risks alongside ISO 14971 risk management, ensuring your SaMD meets FDA and EU MDR cybersecurity documentation expectations.