FMEA Development Workshop

Service Description

HeurNova offers immersive, instructor-led workshops that guide cross-functional teams through the structured development of Design (DFMEA), Process (PFMEA), and Use (UFMEA) analyses aligned with ISO 14971, ISO 13485, and AIAG–VDA methodologies. Participants learn to identify potential failure modes, assess severity, occurrence, and detection, and implement effective risk controls linked to design inputs and process validations. The workshop delivers: Facilitated FMEA creation using live examples from your processes or devices Risk-priority number (RPN) or Action Priority scoring and mitigation planning Integration with design verification, CAPA, and complaint systems Templates and customized worksheets suitable for ongoing use By the end of the session, your team will have the skills to develop a completed, audit-ready FMEA and a repeatable framework for maintaining risk documentation in compliance with ISO 14971 and FDA QMSR.