Field Corrective Action

Premier Research provided ongoing regulatory support to an international company specializing in surgical implants. The company identified a problem with one of their products and with the assistance of Premier Research reported it to the appropriate Competent Authority according to applicable MEDDEV regulation. Following the report it was decided that a Field Corrective Action was required in the form of a recall. The notification to all applicable Competent Authorities and recall efforts were supported by Premier Research to achieve full compliance with the regulation.

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