Content by Jon Speer

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Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me...
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Jon Speer
During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483...
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Jon Speer
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation. We’re talking documentation to demonstrate you have a compliant quality...
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Jon Speer
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All...