Post-market Studies

Post-market Clinical Investigation:

For post-market clinical investigations, adherence to the principles outlined in the ISO14155:2020 and other regulations and guidelines is recommended, as far as they are relevant, taking into account the nature of the clinical investigation. According to this standard, post-market clinical investigations are conducted subsequent to the market approval of a medical device. Their purpose is to address specific inquiries concerning the clinical performance, effectiveness, or safety of a medical device when used in accordance with its approved labelling. In comparison to pre-market studies, post-market investigations may benefit from certain exemptions outlined in the standard, making these studies administratively simpler.