Michael Zagorski

Michael Zagorski has a diverse work experience in the field of quality and regulatory compliance. Michael has served as the Director of Quality and Regulatory Compliance at ImPACT Applications, where they were responsible for implementing a full quality management system compliant to ISO 13485, FDA QSR, and CMDR. Michael obtained ISO 13485 certification, De Novo, and 510(k) clearances for the company. Prior to that, they worked as an independent consultant, providing quality and regulatory compliance consulting for start-up and small medical device firms. Michael developed and implemented Quality Management Systems processes and procedures compliant to FDA QSR, ISO 13485, MDD, CMDR, and others. Michael also had a role as the Director of Q&R at Sway Medical, where they worked on balance assessment software using mobile devices. Michael has also worked at Philips Healthcare as a Regulatory Engineer and Design Quality Engineer, where they prepared submissions according to FDA guidelines, defined regulatory strategies, and ensured compliance to quality procedures and external standards. In addition, they have experience as a Product Development Engineer/ Consultant at Rheomedix, where they were involved in all aspects of new product development for a wireless respiration monitor. Michael also worked as an Adjunct Instructor and Research Assistant at Drexel University, teaching and developing labs for analog electronics and assisting in research projects. Michael founded an R&D company called Skryba LLC, where they were involved in the development of products for consumer and medical devices industry. Michael has also worked at Lockheed Martin Commercial Space Systems as an Electronic Staff Engineer and at Maida Engineering as an Electrical Engineer.

Michael Zagorski has a Master of Science (MS) degree in Engineering Management from Drexel University. Michael also holds a Bachelor of Science (BS) degree in Electrical Engineering and another Master of Science (MS) degree in Biomedical Engineering, both from Drexel University. In addition, they have obtained several certifications including ISO 13485:2016 Lead Auditor (TPECS) from BSI in September 2019, Certified Quality Auditor from the American Society for Quality in June 2009, Regulatory Affairs Certification (RAC-US) from the Regulatory Affairs Professional Society in December 2012, and Certified Quality Engineer from the American Society for Quality in December 2010.