Products
-
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
-
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
-
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
-
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
-
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
-
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