The medical device industry is heavily regulated and inadequate product complaint handling accounts for a large percentage of FDA inspection findings. Complaint handling represents an emerging issue that device companies need to address. Increasing regulatory and public scrutiny as a result of numerous product issues that impact patient safety have jarred the public’s trust. Companies have various functional groups that interact with the complaint which leads to a complex process with multiple handoffs, and therefore a lack of controli. This complexity leads to several variations in the way complaints are being handled by different companies.

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