Overview

Michael Zagorski has extensive experience and expertise in all aspects and phases of a product development lifecycle - from feasibility and research, through post-production - and brings a practical, pragmatic and flexible approach helping medical and heath technology companies meet global regulatory requirements.

Michael brings fresh insight into managing quality system and expertise in domestic and international regulations for medical devices and healthcare technology.  He has worked with many small and large organizations in the medical device and engineering industries, including leading companies such as Philips, Lockheed Martin, and General Electric. He also provides guidance and support to medical device start-ups with all aspects of Design Quality and Risk Management, Quality Systems, and Regulatory Affairs.  

Read more

Michael's experience includes all aspects of Quality & Regulatory Affairs for a medical device software start-up that measures, documents and tracks a patients/athletes objectively measured outcome. As Director of Q&R, he managed the full implementation of a quality system compliant to FDA QSR and ISO 13485. He directed regulatory affairs, including international strategy, submission preparation, labeling/claims review, regulatory intelligence, product portfolio analysis, and due diligence. Michael oversaw quality systems and quality assurance programs, including management review, audit management, CAPA/Investigations, product development, design changes, risk management, and usability and clinical performance validation studies, among other areas.

Michael also previously served in various positions at Philips Healthcare, a world wide leader in professional healthcare products and solutions. As a Regulatory Engineer he prepared and submitted 510(k)’s, IDE’s, and other product submissions according to FDA guidelines. He defined regulatory strategies and provides regulatory advice, support and expertise to assigned product development projects from technical approach to post marketing phase. He was responsible for analyzing and creating internal regulatory assessments for new product releases, product modifications and service notifications. As a Design Quality Engineer, Michael was responsible for ensuring compliance to company quality procedures and forms as well as external standards (ISO13485, ISO14971) and all regulatory requirements (FDA QSR, MDD, CMCDAS) for new and sustaining product development efforts and supported product commercialization by serving as QA department's representative on organizational development teams.

Michael has also made his mark in academia, serving as an adjunct instructor and researcher at Drexel University. 

Read less

Focus Areas

Services

Credentials

Education

  • Drexel University (M.S.)
    • Engineering Management
  • Drexel University (M.S.)
    • Biomedical Engineering
  • Drexel University (B.S.)
    • Electrical Engineering

Events

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.