Case Study: Life Support System Risk Analysis

A medium-size manufacturer of a complex electromechanical, software containing, life-support system was short of trained staff, yet needed a full risk assessment on a tight schedule in preparation for a 510(k) submission.

An experienced AlvaMed team was quickly able to understand the product and lead the Hazard Analysis and pFMECA efforts at both the system and module levels. Working both on and off site, the AlvaMed consultants simultaneously trained the client’s staff in the methodology.

The risk analyses were completed on time; AlvaMed training and risk analysis document templates gave the client the confidence to perform future risk analyses themselves.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control