The scope of NoBoMed Co. Ltd. is an accredited system certification organization according to the MSZ EN ISO 17021-1 standard, which is the system certification of medical device manufacturing organizations according to the EN ISO 9001:2015 and EN ISO 13485:2016 standards. The certification activity is carried out by a highly qualified and competent auditor staff. With the supportive yet consistent activity our goal is to ensure that only those in vitro diagnostic devices and medical products will be placed on the market that are complying with the regulations and supporting the safe patient care.
NoBoMed Co Ltd. is currently in the preparation phase. Our primary goal is to submit the application for IVDR designation and obtain the designation in the shortest possible time and to start conformity assessment activities for our customers
I graduated on Faculty of Medicine, Semmelweis University. I started working as a doctor in National Korányi Institute and after spending the practical time in Institute for Rheumatology and Physiotherapy, I successfully passed the professional exam.
I have been working for different pharmaceutical companies since 1995 and since 1998, I was working on the field of clinical studies as official expert. Between 2006 and 2011, I have been working as regional research leader at MSD and I have built up and controlled the clinical study of six countries. Then, after a shift, I became the chairman of medicine at National Pharmaceutical Institute between 2011 and 2013. In 2013, I temporarily went back to the pharmaceutical industry, and I was the medical chairman of the MSD until 2015. Between 2015 and 2018, I was the chief chairman of the National Institute of Pharmacy and Nutrition, and I had the possibility to make my visions regarding the transformation of the Institute come true and we stepped into the 21st century leaving the classic pharmaceutical authority behind, and we created a new, conforming institute for the challenges of the new age.
As a result of it, the institute joined all those fields that they directly or indirectly have an effect on the human body and that have a physical, pharmaceutical and any other type of impact, so called: medicine, medical device, nutrition, food supplement, cosmetics etc. During this period, as Hungarian member of the European Medical Agency’s (EMA) Governing Board I had the opportunity to take part in the development of the European long-term medicine strategy.
Since 2017, as honorary PhD and rector advisor of the DEOEC I help the highlighted developments of the university. Since 2020, I’m the chief medical director of DRC (Drug Research Center, Balatonfüred). NoBoMed Zrt. has been established in 2022. As chairman of the management board, my mission is to provide high-level services for the development of the medical device industry with my previous experiences and knowledge and with the great professional personnel and services of the NoBoMed.
Dr. Pozsgay Csilla, chairman of the management board
Our mission is to continuously ensure the quality, safety, performance, and conformance according to the relating requirements of the marketed and distributed medical devices and in vitro diagnostic medical devices certified by us. We are committed to the highest-level professional performance regarding our audits and certification procedures therefore promoting the safe and easy marketing for the manufacturers and distributors of medical devices.
As a certification body of medical devices and in vitro diagnostic medical devices we are dealing with the following areas:
We are making sure that the medical devices conform the relating legal. quality and standard requirements.
By the certification of the quality management system we are making sure that the manufacturing and distribution of the medical devices is safe, traceable and conforming the relating requirements in order of the conforming application of them both by patients and healthcare professionals.
During the certification process of medical devices and in vitro diagnostic medical devices we are inspecting that these devices conform the relating local and international legal regulations, standards and other regulations. Conformity regarding the medical device and in vitro diagnostic medical device regulations and other regulatory requirements is included.
As significant member of the domestic and international market of medical devices, we take a significant role with our professional and educational activities according to form an environment that preserves values and innovative, therefore as the result of our activities we become the chosen partners of our clients.
