Mike on Medtech: Quality vs. Regulatory

Mike on Medtech: Quality vs. Regulatory

Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.

By Sean Fenske, Editor-in-Chief03.02.18
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two terms that are sometimes used interchangeably, but are, in fact, unique in purpose and definition—quality and regulatory. Should they be best treated as separate entities or addressed as a unit? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion:

  • What’s the difference between quality and regulatory?
  • Should we separate quality and regulatory?
  • Would we have fewer problems if we did not separate them?
  • What are the challenges for the future?
  • Real world and medical device industry examples provided.

Listen to the podcast streaming via the player below or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about the differences between quality and regulatory, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other episodes of Mike on Medtech.
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