About TytoNyx

Roma Shusterman

Roma Shusterman, Ph.D. is a MedTech R&D leader and entrepreneur. He has led the development of wearable neuromodulation systems, high-density EEG platforms, and ML based SaMD, achieving multiple FDA 510(k) clearances for clinical tools in epilepsy and sleep medicine. He co-founded TytoNyx to empower both innovators and the wider healthcare community by transforming regulatory compliance from a barrier into a catalyst. TytoNyx serves as an end-to-end regulatory and quality partner, minimizing time and cost along the entire product lifecycle while ensuring the highest standards of patient safety. By streamlining audits, automating submissions, and embedding compliance into development, Roma's vision is to free MedTech teams to focus on delivering safe, effective, and lifesaving technologies to patients faster.

John Giantsidis

John Giantsidis, as the CEO of Veridat and President of CyberActa, Inc, partners with innovators in heavily regulated industries to enable global data-driven digital, regulatory, cyber, and commercialization solutions. He is the Vice Chair of the Florida Bar Standing Committee on Cybersecurity and Privacy Law, a former advisor of Software Transparency Group, US Dept of Commerce, National Telecommunications and Information Administration and Past Voting Member, AAMI® Health IT Committee & Device Security Working Group. John held various leadership roles with Bristol-Myers Squibb Co., Fresenius Medical Care, among others. John holds a Bachelor of Science degree from Clark University, a Master of Engineering from George Washington University and a Juris Doctor from the University of New Hampshire.

Dana Shusterman

Dana is a regulatory and quality leader who founded Tytonyx to help medical device companies bring innovative products to market with confidence. She has successfully guided FDA 510(k) submissions, EU MDR Technical Files, and international registrations across 20+ countries—all with a spotless audit record. With deep expertise in ISO 13485, MDSAP, and quality management systems (QMS), Dana has built and led programs that not only meet global regulatory standards but also drive efficiency and innovation. Her vision for Tytonyx is to transform compliance and quality assurance into engines of trust, speed, and sustainable growth.

Maria Papademetris

Maria Papademetris is a Corporate Development Engineer at CyberActa, focusing on emerging technologies in regulatory compliance and drug development lifecycle management. She holds a Bachelor of Science in Chemical Engineering from Yale University, where she did research on SaMD in cancer diagnosis, and her previous work also includes a role at CyberActa as a regulatory policy analyst, writing about AI in regulatory strategy and developing as a clear and effective communicator of technical topics. At Tytonyx, she leverages her experience in highly regulated project environments to guide clients to submission, maintaining an intuitive relationship with quality assurance.

Ihor Rabodzei

Ihor Rabodzei, M.Sc. in Cyber Security and Software Engineering, Head of Engineering at Tytonyx with 9+ years of experience leading commercial development, specializing in scalable systems, secure architectures, and driving product innovation.

Zakhar Ostrovskyi

Zakhar Ostrovskyi, Ph.D. candidate in Computer Science, is an AI Research Engineer at Tytonyx with 5+ years of experience building advanced AI solutions for BioTech and MedTech. He specializes in generative AI and agentic systems to accelerate innovation and streamline compliance.