Inhalation Sciences AB (ISAB) presents schedule regarding clinical validation of PreciseInhale
(Stockholm, 21 October 2020) Due to the COVID-19 situation, and the transition from MDD (Medical Device Directive) to MDR (Medical Device Regulation) which places greater demands on regulatory documentation, quality systems and risk management prior to clinical trials, ISAB presents its plan for the clinical validation of PreciseInhale.The COVID-19 pandemic has affected all ongoing and planned clinical trials globally. Patient recruitment has come to a complete halt during the pandemic and is expected to resume at a slow pace during the winter of 2020. In the planned clinical study, ISAB