Medical Device Software Process Blackbelt

Explore the global regulatory landscape for medical devices, focusing on the FDA framework, risk-based classifications (class I–III), 510(k) clearance, PMA, and quality systems (GMP, QSR) under 21 CFR.

Explore FDA design controls under 21 CFR 820, aligned with ISO 13485, showing how planning, input, output, reviews, verification, validation, transfer, changes, and risk management shape medical device software process.

Explore the medical device software process within a quality system. Link risk management to the software life cycle under FDA 21 CFR Part 820, ISO 13,485, IEC 62,304.

Establish a quality management system aligned with ISO 13485 to govern design, development, production, installation, and servicing of medical devices, including validation and continual improvement.

Identify hazards, analyze risks, and implement controls for medical device software, evaluate residual risk, and ensure risk acceptability under ISO 14 1971, integrating safety and security risk management.

Learn to perform requirements analysis for medical device software per IEC 60,304, defining, reviewing, and tracing functional, security, and user interface requirements from risk analysis through software requirements specification.

Translate software requirements into an architecture, define major software items and interfaces, specify functional and performance requirements, and support risk management and safety classification.

Implement and verify software units by translating detailed design into source code, following coding standards, and conducting white box unit tests with statement coverage, branch coverage, and m-cdk coverage.

Coordinate testing, QA, documentation, and deployment to deliver iterative and final production releases; ensure verification, anomaly tracking, and release notes across the software life cycle.

Integrate security throughout the software development life cycle with threat modeling, exploitability-based risk assessment, safety risk management, ISO 14 971, tier 57, and FDA cyber security guidance.

Explore the structured problem resolution process for medical device software, from problem identification and root-cause analysis to change control, testing, and documentation for reliable, safe software.

Follow the FDA’s final cybersecurity guidance and 524 B updates for software-enabled medical devices, outlining security objectives, scalable documentation, proactive labeling, and total product life cycle readiness.