Amie Smirthwaite
Senior Vice President, Intelligence and Innovation RQM+
- Amie Smirthwaite has a PhD in biomedical engineering and undergraduate degrees in biomedical engineering and mathematics. She has 30 years’ experience in medical devices, spanning new product development, regulatory and quality, with a particular focus on clinical evidence. She leads RQM+’s Intelligence and Innovation team.
- Amie joined RQM+ in May 2020, following 12 years at BSI, where she was Global Head of Clinical Compliance. She established BSI’s clinical compliance team and led clinical aspects of BSI’s successful designation under both MDD and MDR. Amie has been involved in numerous expert working groups within the EU, determining requirements for the interpretation and implementation of clinical evidence.
- As a member of the European Commission Clinical Investigations and Evaluations Expert Group and other European Working Groups, she contributed to many MDCG and MedDev guidance documents, including guidance on SSCP, “sufficient clinical evidence”, equivalence, PMCF, and PSURs.
- 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).
- Amie has developed extensive training materials in clinical evaluation, technical file construction, biological safety, risk management and ISO 13485. and has trained hundreds of manufacturers and notified body reviewers in these requirements.
