MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) is pleased to announce the expansion of its digital health and cybersecurity franchise. With the goal of supporting 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 US and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance.
MCRA's digital health and cybersecurity services are focused 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. MCRA offers its expertise 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, interoperable systems, 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, Inc. He has been invited to speak on medical device and critical infrastructure cybersecurity at the Food and Drug Administration (FDA), National Institute of Standards and Technology (NIST), United States Postal Service (USPS), and SANS Institute. Mr. Tugman is an Alumni of The MITRE Corporation where he worked on healthcare related projects with the Department of Defense (DoD), Department of Veterans Affairs (VA), and Department of Health and Human Services (HHS).
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.”
About MCRA, LLC: Founded in 2004, MCRA is a leading medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA's value contribution rests within in its industry experience at integrating five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance to provide a dynamic, market leading effort from concept to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC,
Manchester, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics and in vitro
diagnostic (IVD) devices.