The FDA Recall Epidemic is not over.
How can your company take chances on future FDA recalls when a method exists that tells you how to reduce their probabilities in a straightforward manner?
Drop risks by what you need.
Reduce them iteratively and incrementally until residual risks are acceptable and outweighed by benefits.
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FDA medical device recalls
were down 22% in FY2019. 
That’s good. Just don't open the champagne yet. Device introductions dropped 15% as well. And, correlation with recalls has held at about 96% begining in FY2003. Those changes in recalls come from basic economics, not poor risk management. And not from the Wuhan CVD-19 virus. That came in FY2020.
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Recalls fell again in FY2019. But, their 96% correlation kept pace with new devices on the market. Don't resign to this fate. Every device manufactured is another opportunity for faults and recalls at these same rates. 5 WAYS TO STOP FDA RECALLS
The method is free. And, so is remote consulting help, for the first 100 that interview, with the implementation while this terrible COVID-19 pandemic is upon us. |
