Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Best Practices in Complaint Management - Webinar By GlobalCompliancePanel
2 November 2011, Wilmington, United States
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online training webinar, DE, 1000 N West Street Suite,, Wilmington, 19801, United States
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