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Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we’re going to be talking to Mike Drues, the president of Vascular Sciences, about the lessons that companies have learned from their not-so-successful FDA inspections. You can learn from them, too! 

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Some of the highlights of the show include:

  • Jon’s story of a situation where a company was completely unprepared for an FDA inspection years after their product went to market.
  • The difference between not having the required information and having the required information in a format that’s unacceptable to the FDA.
  • What companies can do to prevent problems with FDA inspections.
  • The importance of knowing what you know and knowing what you don’t know and knowing the difference between the two.
  • Why it’s so important to consider the root cause of troubles with FDA inspections. Many times, the root cause is a tick-the-box mentality.
  • Best practices for being prepared for an inspection.
  • Why an independent audit might not be an effective way to know that you’re prepared for an inspection, as well as tips on knowing whether your auditor is beneficial.
  • Why it’s good to purposely inject a problem into your process to be sure that your quality control system will detect it.
  • The importance of taking a holistic approach rather than only looking at issues one at a time.

Links:

Mike Drues on LinkedIn

Vascular Sciences

Jon Speer on LinkedIn

greenlight.guru

FDA.gov

FDA Warning Letters

Quotes: 

We are talking about people’s lives here... we have the obligation to do what we can to prevent problems.” -Mike

If you’re going to be in the medical device industry, educate yourself and know what the rules are.” -Jon

Know the rules. Before you get on the football field... or before you get behind the wheel of a car, you need to know the rules. The medical device industry is no different.” -Mike


About The Global Medical Device Podcast:
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The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.