Andre Moreira

André Moreira is a Medical Devices Director and Quality & Regulatory Affairs expert with more than 10 years of extensive experience supporting the development, regulatory compliance, and lifecycle management of medical devices and in vitro diagnostic medical devices (IVDs). He has worked with medical device manufacturers and economic operators across the MedTech sector, leading the implementation and maintenance of quality management systems and supporting regulatory compliance under the European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). His expertise includes ISO 13485 quality management systems, technical documentation, risk management, clinical evaluation, biocompatibility, post-market surveillance and post-market clinical/performance follow-up. Throughout his career, André has contributed to a broad range of medical devices and IVDs, including infusion and blood transfusion systems, dental devices, orthodontic aligners, drug-device combination products, and other innovative healthcare technologies. Since 2022, he has been a qualified auditor for ISO 9001 and ISO 13485 quality management systems, and MDR 22017/745.