Amie Smirthwaite

Senior Vice President, Scientific Affairs at RQM+

Speaker

Amie has a PhD in biomedical engineering and undergraduate degrees in biomedical engineering and mathematics. She has 30 years’ post-doctoral experience in medical devices, spanning new product development, regulatory and quality, and policy development in both the UK and EU. She joined RQM+ in May 2020, following 12 years at BSI, where she was Global Head of Clinical Compliance. In this former role, she established BSI’s clinical compliance team and led clinical aspects of BSI’s successful designation under MDD, MDR and IVDR. Amie has been involved in numerous expert working groups within the EU, determining requirements for the interpretation and implementation of clinical evidence and postmarket surveillance, and has contributed to many MDCG and MedDev guidance documents, including SSCP, “sufficient clinical evidence”, equivalence, PMCF, and PSURs. She is contributing as Committee Expert for the European Commission Clinical Investigations and Evaluations Working Group. Amie is currently a member of ISO technical committees CH/194 (Biological and clinical evaluation of medical devices), CH/150 (Implants for surgery), and CH/210/4 Risk analysis for medical devices, and is on the Advisory Boards of NORE (Network of Orthopaedic Registries of Europe) and CORE-MD (Coordinating Research and Evidence for Medical Devices, European Union Horizon 2020 project). She recently drafted a standard for clinical evaluation of medical devices which has been accepted as a current work item under both ISO and CEN (ISO 18969).