Non-clinical bench testing is the objective evidence that a medical device meets its design inputs before it reaches a patient. Bench-testing protocols — key evidence in any 510(k), De Novo or PMA — require command of the chain from risk analysis (ISO 14971) to test selection (IEC 60601 for electrical safety, IEC 62366 for usability, the modality-specific IEC 60601-2-XX collaterals, applicable ASTM methods), through the statistical plan (sample size, quantitative acceptance criteria) to evidence defensible before an inspection or notified body. The FDA Safety and Performance Based Pathway offers an alternative to the classic 510(k) built on demonstrating conformance to objective safety and performance criteria.

This instructor-led online course prepares students to develop risk-management systems and design non-clinical bench-performance tests that support regulatory submissions for medical devices and IVDs. Across ten modules, students explore the FDA Safety and Performance Based Pathway, usability-centered design validation under IEC 62366-1, structured hazard methodologies (FMEA, FTA, hazard analysis), the ISO 14971 risk-control hierarchy, IEC 60601 electrical safety and essential performance, and benefit-risk reasoning that integrates clinical benefit with residual-risk profile. Students select a working device in Module 1 that serves as the substrate for each weekly deliverable, building toward a final project: a Risk Management File, Risk Management Report and benefit-risk analysis.