Further to my participation in the panel organized by Hellenic Digital Health Cluster (HDHC) and moderated by Mr. Dimitrios Katehakis, entitled: «Teleconsultation in Greece: From Policy Framework to Real-World Implementation», I would like to highlight the following:
EKAPTY S.A., as the only Greek Notified Body designation forthcoming, will ensure the compliance of medical devices and Software as a Medical Device (SaMD) with MDR, by assessing the safety and performance of telemonitoring systems and clinical data management solutions.
Furthermore, EKAPTY S.A. provides certification in accordance with ISO 13485 and specialized training in collaboration with the National and Kapodistrian University of Athens and other University Institutions, aiming at the harmonization and effective integration of digital health technologies, while simultaneously planning the advancement of certification schemes for Teleconsultation and Telemedicine Systems, which constitute the future of Medicine worldwide.
Based on the principles of ethical conduct in the provision of healthcare services, certification at every stage of this modern transition becomes essential.
Scientific societies evaluate and synthesize medical data by developing evidence-based clinical guidelines, while suppliers contribute real-world data and technological infrastructure. Their collaboration reduces clinical uncertainty and enhances the quality of care through documented and validated practices.
EKAPTY S.A. operates as the connecting link between science and health policy, assessing and certifying medical devices in accordance with international standards. It translates technical specifications into structured recommendations and safeguards Public Health through its supervisory role, including the authority to withdraw certificates when necessary.
In conclusion, the institutional safeguarding of innovation in healthcare requires synergies, transparency, and a clear regulatory framework. EKAPTY S.A., by consistently fulfilling its role, ensures that technological progress advances in parallel with safety and quality. With a steadfast commitment to Public Health to the human being and to institutional credibility, it substantially contributes to shaping a modern, reliable and sustainable digital health system for the benefit of patient, potential patient and society.
With honor, responsibility and optimism,
Dimitra A. M. Pappa
Chief Executive Officer (CEO) & President of the Board of Directors of EKAPTY S.A.
