Clinical Validation


The clinical approbation will be performed in partnership with a clinical research organization, the university clinic SOTE. EU level legal requirements will be followed.

Semmelweis University is widely recognized as one of Europe’s leading centers of medicine and health sciences. With its 238-year-old tradition of academic excellence our University ranks among the most prestigious Hungarian research institutions where 1172 staff members in approximately 80 departments are involved in R&D activities. Research projects in the preclinical and clinical departments are supported by both Hungarian and international programs. Contract research sponsored by pharmaceutical companies is also an important part of scientific activity. Selected research groups are supported jointly by the University and the Hungarian Academy of Sciences. 

Semmelweis University is one of the recognized members of a vast network of biomedical science; it is the site where academy and industry come together, where the meaning of the term multidiscipline really exists. The Szentágothai János Knowledge Center (SJKC) is a center of excellence initiated by Semmelweis University and supported by the National Office for Research and Technology. The consortium also includes Richter Gedeon Ltd., a leading Hungarian pharmaceutical company, the Faculty of Information Technologies of Pázmány Péter Catholic University and the Institute of Experimental Medicine (Hungarian Academy of Sciences). 

The involved staff will be led by István Kocsis who is the Head of Neonatal Services at the Semmelweis University’s 2nd Department of Obstetrics and Gynecology.

Outcome: Documented and published clinical approbation results, confirming compliance to legal requirements, and a high impact publication the beyond state-of-the-art treatment performance.

Criteria for success: 

  • Compliance to all standards
  • Successfully obtaining all certifications
  • Successful clinical validation