16th December 2022

In countries around the world, MDs undergo a distinctive process from ideation, design and development phase, up to testing, approval and certification before the production, production process itself and post-market surveillance (PMS). Produced medical devices must comply with health, safety and environmental protection requirements defined in regional and/or national directives and regulations. Read more on the research article published on the Technology and Health care Journal by Prof. Almir Badnjević.

Mechanical ventilators are medical devices used in intensive care units when patients are in need of mechanical aid to facilitate the process of breathing. As the function of breathing is the exchange of gases, the mechanical ventilator takes over that function while the patient is incapable to spontaneous breathing. As these devices are used to maintain the life of patents, their performance must be ensured and there cannot be significant deviations in the volumes and pressure of gases they introduce to the patient. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. Read more on the research article published on the Technology and Health care Journal by Prof. Almir Badnjević.