What is a regulatory strategy? What are the components involved?
In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy.
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Premarket Approval Application (PMA)
MedTech True Quality Stories Podcast
Greenlight Guru YouTube Channel
“Strategy is a hope for future.” Jon Speer
“Strategy is key. Your strategy is not necessarily to win the game, that’s the outcome. The strategy is how you get there, considering all your different options.” Mike Drues
“I will never tell a company what not to do. I refuse to play the regulatory police.” Mike Drues
“I’m getting sick and tired of people...say they want the quickest, easiest, cheapest way to get their device on the market.” Mike Drues
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.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...