Products
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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.
$1,000
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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
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FDA Cybersecurity Labeling Requirements
Digital downloadThis guide decodes FDA cyber device labeling expectations, providing a checklist to ensure compliance. It helps regulatory and engineering teams verify required security documentation and user instructions to streamline premarket submissions.
Free
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Cybersecurity evaluations for medical devices
Digital downloadThis guide helps teams navigate FDA, UL 2900, and IEC 81001-5-1 requirements. It includes a standards mapping table, a premarket submission checklist, and strategies for the 4 layers of security testing to ensure regulatory alignment.
Free
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Parameter Diagrams for Robust Design
Digital downloadParameter Diagrams for Robust Design offers a systematic way to prevent late-stage failures. It includes an auto-calculating Excel template, guidance on 5 noise factor categories, and methods to link data to Design Inputs and FMEA.
Free
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Design Review Scorecard Guide
Digital downloadStop "box-checking" and start improving outcomes with this Design Review Audit Kit. Includes Word scorecard using 18 criteria across 5 dimensions. Get objective scoring guidance and clear action-based thresholds.
Free