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Clinical research organization MCRA has expanded its digital health cybersecurity franchise. To support the growing trend of organizational and medical device specific digital health commercialization, MCRA has hired Jason Tugman as its new Associate Director of Cybersecurity Risk Management and Strategy, integrating with MCRA’s five core service areas of U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance and Quality Assurance.
MCRA’s digital health and cybersecurity services focus on the entire technology lifecycle continuum, from FDA submissions to pre- and post-market cybersecurity assistance, as well as corporate-wide organizational cybersecurity advisory support. This expertise is offered for all FDA regulated technologies and services including implantables, clinical trials, mHealth, telehealth-care, Medical Device Software such as medical mobile apps and artificial intelligence algorithms, connected medical devices, health analytics and wearables.
Prior to joining MCRA, Mr. Tugman was the Vice President of Cyber Risk in the medical device sector at Axio Global. He has been invited to speak on medical device and critical infrastructure cybersecurity at FDA, National Institute of Standards and Technology and other entities. Mr. Tugman is an Alumni of The MITRE Corporation where he worked on healthcare related projects with the Department of Defense, Department of Veterans Affairs and Department of Health and Human Services.
Nikki Batista, Associate Director of Regulatory Affairs said, “As we continue to support the digital transformation in healthcare, it is important that MCRA provides the necessary expertise to our clients. Mr. Tugman is a recognized expert with an extensive background in medical device cybersecurity, and his appointment reflects MCRA’s strong commitment to providing first-in-class regulatory and cybersecurity services to the medical device community. Our team is delighted to have Jason join us.”
Jason Tugman said, “I have spent my career working with technology innovators. Cybersecurity has become a critical path to success for FDA approvals and clearances as well as post-market activities. I am thrilled to join the MCRA team in expanding its ability to support medical device innovators.”
