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Good People Working on Good Projects with Good Process

Case Study 3: Recall Quality System

Situation Midsize class II device manufacturer needed risk management quality support and recall advise.
Frestedt Approach
  • Updated SOP,WI and template for ISO 14971 compliant system
  • Met with team and trained on implementation
  • Continuing service as quality and regulatory service provider for issues like a class III recall for a device dysfunction
Results Frestedt continues as the quality and regulatory support for this company. Company is fully operational with an active and successful updated RM program in place.