MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations
This blog delves into the changes in the MDCG 2021-6 Revision 1 and NAMSA Experts’ take on what the changes mean for manufacturers.
Month: December 2023
European Heart Journal: Randomized Controlled Trials Are Not Always the Solution
European Heart Journal Article | Published 13 December 2023 By Sara Finocchietti (NAMSA Senior Strategy Consultant, Clinical) The recent article authored by Siontis et al.1 has made considerable contributions to the ongoing debate concerning the pre-market clinical evaluation of implantable medical devices in Europe, with a particular focus on the cardiovascular domain. The study encompassed seven different … Continued
MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance
This blog delves into the changes in the MDCG 2022-11 Revision 1 and NAMSA Experts’ take on what the changes mean for manufacturers.
Five Reasons Not to Delay Your MDR Certification
This blog delves into the approaching deadlines and reasoning for moving forward with MDR certifications now.