ZenStorming Solutions, LLC, was founded by Michael Plishka, an accomplished product
design and developer with over 17 years of experience in the medical device arena.
In addition to his work as a product developer, he has applied his design thinking skills in developing and optimizing quality and risk analysis systems that help and even expedite the product development process. These systems have withstood the tests of audits and his well structured 510(k)’s have garnered the praise of FDA reviewers.
Plishka’s grasp of the medical device world is highly respected as he was invited
to present, “Working with Medical Device Companies -
He also has over 15 patents issued and pending in the US and internationally. He is an accomplished performing musician and artist who teaches and writes with joy and passion. In addition to his Bachelors in Mechanical Engineering he has a Masters of Arts degree.
To find out how Michael Plishka can help you with your regulatory issues in medical device development, please contact us.
