Products
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UEHF Awareness for Medical Devices
CourseAwareness-level usability engineering and human factors for managers, team members and suppliers: use errors, the use specification, URRA and critical tasks, interface design, formative evaluation, HF validation and FDA submissions.
$249
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DFMEA Awareness for Medical Devices
CourseLearn to read, review and question a Design FMEA in about 2.5 hours. For managers, team members, new hires and suppliers: the failure chain, S/O/D ratings, prioritization, and how the DFMEA links to verification, PFMEA and ISO 14971.
$249
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Technical Training ROI Calculator
Digital downloadRework consumes 40–50% of development costs. This spreadsheet turns that into your number: enter eight inputs, get your payback period and first-year ROI. Built from FDA and McKinsey data.
Free
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Usability Engineering and Human Factors (UEHF) for Medical Devices
CourseUE and HF Engineering apply scientific knowledge of human behavior, capabilities, and limitations to medical device design, ensuring safe, effective, and satisfying use throughout the product lifecycle while optimizing usability.
$1,500
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Design Failure Mode and Effects Analysis (DFMEA) - English
CourseDesign FMEA is a systematic method for identifying potential failures in a product's design by assessing their severity, occurrence, and detection and then prioritizing corrective actions to prevent design defects and ensure quality.
$1,500
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ISO 14971 Safety Risk Analysis Requirements
Digital downloadBuild a Risk Analysis that survives an ISO 14971 audit. Get the hazard-to-harm framework, severity and occurrence scales, the 5×5 risk matrix, the RCM hierarchy, and a scored completeness checklist to catch gaps before a reviewer does.
Free