Michelle Ackermann

Background

About Michelle Ackermann

Regulatory Affairs professional with engineering background and 25+ years of experience in the medical device industry. Extensive and direct FDA premarket regulatory experience including authoring and negotiating clearance/approval of 510(k) premarket notifications, original PMA Applications, PMA Supplements, 30-day notices, PMA Annual reports, and Pre-Submissions for complex Class 2 and Class 3 software-driven electromechanical cardiovascular devices. FDA submission experience with software verification and validation, EMC, wireless technology, cybersecurity, interoperability, risk management and human factors. Serve as regulatory technical leader and advisor in developing and implementing clear and effective regulatory strategies and providing strategic and technical guidance to cross functional team members throughout product lifecycle.