Modernizing Risk Analysis in Medical Device Development

The traditional risk analysis FMEA-spreadsheet is becoming obsolete in the face of the ever-increasing amount of information required to fulfill the evolving standards and demonstrate and maintain compliance with regulations. The challenge to produce accurate, consistent, and meaningful data is amplified using generic tools like FMEA-spreadsheets.Over-reliance on FMEA as the prominent risk analysis technique has hindered the application of new principles introduced by evolving standards. This makes risk analysis processes highly complex and inefficient.This report explores how specialized software tools address these challenges to support risk management processes with structured templates, automated calculations, inherent data integrity, version control, audit trails, and integration with design and test data.