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The results are in from our Square-1 Engineering online poll...."What are the top 2 most frequent reasons warning letters/ citations are issued by the FDA?"
Listen in as our managing director, Travis Smith, covers the results of he poll while sharing commentary from the medical device community. Need help dealing with an audit or warning letter? Learn more about our support capabilities at https://lnkd.in/g7NX_8pw #poll #fda #capa #complaints #regulatory #quality #medtech #square1engineering
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 Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients. The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing locations domestically. As you can guess our clients’ situation was dire due to several implant failures in the field. We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project. 
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