It is with great pleasure that we welcome Ann Lebar to the MedSec Team as a Principal Consultant. Prior to joining MedSec, she held a variety of roles in regulatory affairs and cybersecurity in the medical device industry. Starting out as a Quality and Regulatory Compliance Engineer for the software platform business group, Ann quickly advanced to Lead Safety and Regulatory Engineer for multiple groups including X-Ray, Global Service Tools, and Software Applications. She has authored global regulatory submissions such as FDA 510(k)s, EUMDR, and China NMPA for electromechanical (hardware + software), software-only, and hardware-only medical devices. Ann simultaneously led several international teams in multiple business units in both the premarket and post market regulatory space.
Her ability to stay calm and focused amidst controversy and her diplomatic approach to problem solving, resulted in executive management selecting her to tackle time-sensitive, highly visible, compliance issues involving partnership with various regulatory branches and privacy sectors of international Ministries of Health.
Ann moved into leading medical device submissions to the US Department of Defense (DoD). Her work with both the engineering teams and the DoD leadership sparked her interest in cybersecurity. Ann’s combined experience in both engineering and regulatory made her a natural fit for her next move into the central cybersecurity team of a Fortune 500 company. She continued to focus on DoD certifications as well as leading the development of the vulnerability triage and assessment process and tool.
Ann holds a Bachelor of Science degree in Biomedical Engineering with a minor in Electrical Engineering and a Master of Science degree in Biomedical Engineering (with an emphasis in digital signal processing) from Marquette University. She has published several technical papers in technical journals including IEEE Transactions on Rehabilitation Engineering, Journal of Rehabilitation Research and Development, Proceedings of the 15th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, International Conference of the IEEE Engineering in Medicine and Biology Society, and Archives of Physical Medicine and Rehabilitation.
Ann’s regulatory, engineering and cybersecurity background in the medical device industry expands our team’s expertise to the next level. We eagerly anticipate her contributions and the value she will undoubtedly add to MedSec as we continue to drive innovation and excellence in our field. Welcome, Ann, to the MedSec family!
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