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Product corrections and removals (Recalls) impact many medical device manufacturers each year and can put your company, your brand and your patients at risk.
If managed poorly, a recall can have devastating consequences on a your reputation, market share, and bottom line while consuming your corporate resources. In extreme cases it may even result in FDA inspectors visiting your manufacturing facilities on a surprise inspection, or even visiting your customers to “persuade” them to comply with the recall requests!
Handled properly, a timely conclusion will minimize financial and regulatory risk while protecting the public health.
Complex regulations and recall logistics demand a partner experienced with medical device recalls and FDA communications. Otherwise, you are not managing your business risks.
Partnering with Vision28 enables you to focus on your core business while our recall experts interface with FDA and quickly and compliantly handle your recall. We can help you:
Properly notify FDA, distributors and customers of a recall
Generate compliant documentation to open, track and close a recall
Submit required monthly Recall Updates to FDA
Perform recall effectiveness checks required by FDA for recall closure
Write and submit recall closure letters
If you are in the midst of a difficult product recall or if you are just planning risk mitigation in the event of a recall, Vision28 can help you meet all regulatory requirements in the most pragmatic way for your business.