18 Mar 2024 | All the News
Theme Clinical investigation plan (CIP) Target Audience Sponsor of clinical investigation Products concerned MD Documents mentioned RDM (EU) 2017/745 – article 70 – annex XV ISO14155:2020 This guide is intended to help sponsors draw up their...
13 Feb 2024 | All the News
Theme Vigilance Target Audience Manufacturers Products concerned Specific devices : cardiac ablation, coronary stents, cardiac implantable electronic devices, breast implants Documents mentioned MDR (EU) 2017/745 – articles 87 et 88, 92 IVDR (EU) 2017/746 –...
