Fimea inspected Nightingale’s regulatory compliance with the requirements for manufacturer of medical device
Press release, 14 October 2021 at 9:50 a.m. (EEST) The authority supervising regulatory compliance of medical devices and actors in the industry, Fimea, has as part of its market surveillance inspected Nightingale Health Plc’s (“Nightingale”) regulatory compliance with the requirements for manufacturer of medical device. The inspection included an evaluation of the manufacturer’s compliance with statutory obligations and required quality assurance, including among other things fulfillment of risk management, change management, document management, customer feedback management and control