Dan Kosednar

Dan Kosednar is the Vice President of Regulatory Affairs at HistoSonics. Dan has over 25 years of experience in the medical device regulatory field and is the author of numerous successful 510(k) Premarket Notifications for Class II medical devices. Dan has also global regulatory experience, having authored many EU Technical Files and obtained approvals and licenses globally.

Dan’s product expertise includes thermal ablation devices, image processing software, anesthesia systems, and critical care ventilators. Dan is experienced with complex electro-mechanic devices containing software and has assisted technical experts with the interpretation/application of international standards and the scoping of Verification and Validation activities required to support regulatory approvals.

Dan has been successful in both large, multi-national device companies and the start-up environment. Dan was a highly valued regulatory leader at both GE Healthcare and Ethicon, Inc. Additionally, Dan was the fourth employee at NeuWave Medical, Inc. and was the sole member of the Regulatory Affairs and Quality Assurance departments. In this capacity, Dan assessed the regulatory landscape, identified predicate devices, conducted Pre-IDE (now Pre-Submission) meetings, approved user and design specifications, determined the scope of V&V activities, drafted User Manual and IFUs, approved marketing materials/websites, and obtained multiple 510(k)s for the entire NeuWave Medical portfolio. NeuWave developed and launched an innovative and market leading microwave ablation system and was acquired by Ethicon, Inc. in 2016.

Dan has been RAC Certified since 2000 and holds a Bachelors of Science from the University of Wisconsin, Madison.

Dan Kosednar received their education from the University of Wisconsin-Madison, where they majored in English. Dan also took a Technical Communications Certificate program through Engineering Professional Development. In addition, they have a Regulatory Affairs Certification from the Regulatory Affairs Certification Program.