Content By Jon Speer

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By: 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 concepts presented is the idea of a risk-based QMS.

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By: Jon Speer

How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other?

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By: Jon Speer

Medical device startups tend to share many common issues. They are usually striving for better resources (such as people and capital) as well as the knowledge and expertise required to deal with the U.S. Food and Drug Administration (FDA) and successfully bring a product to market.

For many startups, a quality management system (QMS) might not appear to be a priority, but I’m here to tell you it needs to be.

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By: Jon Speer

If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and generally making things into a bigger deal than they really need to be.

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By: Jon Speer

If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by someone who is near and dear to you.

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By: Jon Speer

Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.

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By: 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(FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date.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 tell you why.

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By: 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 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $400,000 down the drain.

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By: Alex Morris, 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 management system, that you design and develop products to meet design controls, and that you’re addressing risk management, to name a few.