Supplier Responsibility in Medical Device Recalls
When a medical device recall is initiated, whether a correction or removal, questions often arise related to supplier responsibility. Roberta Goode, president of Goode Compliance International, discusses the concerns that industry has in this area at the 2015 HHE, Risk Assessment and Recalls conference in Washington, DC. What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an organized manner to ensure patient safety.
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