Medical Devices:- Regulatory Compliance: Experience in EU MDR (2017/745), IVDR, FDA 510(k), and other regulations. Proficient in overseeing compliance processes.- Quality Assurance and Management: Development and maintenance of systems in line with ISO 13485 standards, ensuring adherence to high-quality requirements.- Development Models: Application of Agile and V-model in product development processes to enhance efficiency and innovation.- Clinical Trials and Approvals: Oversight of clinical trials and acquiring regulatory approvals for the introduction of new products.- Technical Documentation and Risk Assessment: Compilation of technical documentation and alignment of risk assessment processes with regulatory compliance.Business Development:- Strategic Planning and Implementation: Crafting and executing innovative business strategies tailored to the medical device sector.- Market Research and Competitor Analysis: Exploration of new markets and analysis of competitors to maximize market opportunities.- Grant and Capital Sourcing: Acquisition of grants and capital sources (e.g., venture capital) to support business growth.

The Dennis Gábor Award Winners Club was founded in 1997 with the aim of creating a community of outstanding members of the Hungarian technical intelligentsia to formulate answers to the technical and social challenges of Hungarian society and the world for themselves and the public. The Club now has hundreds of members at home and abroad, including a Nobel laureate, Prof. Ferenc Krausz.

Angiography Redefined, 15,000+ Patients Examined, 200,000+ DVA Images Generated

- Oversaw grant applications and secured funding opportunities for sustainable growth.- Established and maintained relationships with potential investors, enhancing capital acquisition.- Led regulatory compliance for medical devices, successfully navigating MDD/MDR/CE and FDA processes.- Directed sales of medical software to hospitals, while managing marketing strategies, social media presence, and conference appearances.- Managed HR functions, including talent recruitment and development, and handled legal matters.

Our mission is to contribute to a better world through the advancement of modern imaging techniques, cutting-edge science, and innovative ideas. At our research group, we focus on developing imaging technologies, novel molecules, and advanced algorithms that can seamlessly transition into practical applications within everyday clinical settings in the future.In addition to staying at the forefront of the most recent medical and technological advancements, we foster a culture that encourages our team members to not only embrace creativity but also to apply ethical research practices and uphold strong business ethics in their endeavors. This commitment ensures that our work not only pushes boundaries and transforms healthcare but also upholds the highest standards of integrity and social responsibility.Management: - Oversee strategic management and organizational direction within the university research group.Human Resources: - Manage HR functions and cultivate a collaborative and innovative environment among team members.Grant Sourcing and Proposal Writing: - Source funding opportunities, write grant proposals, and secure financial support for research projects.Scientific Project Planning: - Develop comprehensive project plans to drive research initiatives forward and maximize impact.Publication: - Ensure research findings are effectively disseminated through publications to contribute to the advancement of modern imaging and science.Industrial Partnerships: - Maintain relationships with industrial partners to facilitate collaboration and innovation in research.

CROmed’s contract research combines expertise in imaging study design and execution with advanced image analysis. CROmed works with drug development companies and non-for-profit organisations to integrate standard and novel anatomical and molecular imaging methods into research programs to assess drug pharmacokinetics, distribution, targeting and efficacy, explore the mechanism of action and evaluation of novel cellular therapies. CROmed’s team combines expertise in imaging science, physics, radiochemistry, immunology and preclinical imaging to address biological questions with imaging tools.In Vivo Imaging Projects: - Development of Image Processing Algorithms: Responsible for developing and optimizing algorithms to aid in processing in vivo images. - Planning Preclinical Studies: Comprehensive planning and coordination of preclinical studies within in vivo imaging projects. - Acquiring Regulatory Approvals: Responsible for obtaining all necessary approvals, including legal authorizations for preclinical studies and research.