FMEA Framework for Medical Device Development

Failure Mode and Effects Analysis (FMEA) is one of the most used methodologies for quality and reliability and is an effective tool for assessing fault failures, root cause analysis, and failure modes. FMEA is a highly valuable tool to guide the process of development and is required by various industry standards and regulations.

Jama Connect® FMEA Framework assists medical device development teams to conduct comprehensive Failure Mode and Effects Analysis. Download this datasheet for a comprehensive overview of the solution, including:

  • Procedure guides for FMEA for medical device development activities
  • Configuration guide including relationship rules, item types, workflows, pick lists, and attributes
  • FMEA export templates and worksheet view