Skip to main content
RAPS Euro Convergence 2026 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
RAPS Focus
RAPS Focus
Networking Opportunity
Networking Opportunity
Ticketed Event
Ticketed Event
Student Focus
Student Focus

Andreas Oberleitner, MSc (he/him/his)

Chief Regulatory Officer
Platomics, Wien, Austria

Andreas Oberleitner is a regulatory affairs professional with more than 20 years of experience and Chief Regulatory Officer at Platomics, Austria.

Born in 1978 in Klagenfurt, Austria, Andreas studied Electrical Engineering with a specialization in Biomedical Engineering at the Technical University of Graz. He began his career in medical device development, focusing on non-invasive hemodynamic diagnostic devices, where he gained hands-on experience in translating complex technologies into clinically and regulatorily robust solutions.

Over the past two decades, Andreas has worked extensively across the European regulatory landscape under the MDD/MDR and IVDD/IVDR frameworks. Between 2010 and 2020, he was deeply involved in regulatory affairs consulting projects, leading a small regulatory team and supporting companies of all sizes - from early-stage startups to large multinational organizations. His work covered regulatory strategy, quality management systems, and lifecycle support for medical devices and IVDs, and he has served as Person Responsible for Regulatory Compliance (PRRC).

From 2007 to 2020, Andreas also worked as an external lecturer at UAS Technikum Wien, teaching regulatory affairs and contributing to the education of future regulatory and medical device professionals. He is a member of the Austrian Standards Committee on Medical Devices, actively contributing to the development and interpretation of technical and regulatory standards.

Since 2020, Andreas has been Chief Regulatory Officer at Platomics, where he leads the translation of IVDR requirements - particularly those related to in-house IVDs under Article 5(5) - into scalable, digital regulatory solutions. For the RAPS community, he brings a forward-looking perspective on how regulatory affairs can evolve from document-driven compliance toward integrated, technology-enabled regulatory systems that support innovation, quality, and patient safety.

Presentation(s):

Email Andreas