Content by Jon Speer

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Jon Speer
When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should...
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Jon Speer
Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International...
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Jon Speer
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized...
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Jon Speer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for...
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Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food...
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Jon Speer
We raise the corrective and preventive action (CAPA) topic often because it is still something that companies tend to struggle with and find themselves in hot water over, particularly when it comes...
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Jon Speer
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….” That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission...
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Jon Speer
Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going...
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Jon Speer
Corrective and preventive action (CAPA) is an important process for your medical device company. In fact, the U.S. Food and Drug Administration (FDA) states in its Quality System Inspection...
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Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key...