Dr. Amie Smirthwaite
Senior Director - Global Clinical Practice
A clinical and regulatory affairs expert, Dr Amie Smirthwaite has over 25 years’ postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading Maetrics’ global Clinical Practice.
Amie brings a wealth of knowledge and experience having worked for medical device companies, academic institutions and Notified Bodies. Prior to joining Maetrics, Amie was the Global Head of Clinical Compliance at BSI, having been with the organization for 12 years. Amie developed BSI’s clinical compliance team in response to emerging requirements from Commission Implementing Regulation 2013/920 and the publication of the EU Medical Device Regulation. She was a member of the team spearheading the organization’s successful submission to achieve EU MDR designation. She has been an active member of European Commission Working Groups for clinical evaluation and post-market surveillance, representing Team NB and NBMed.
Amie is also a member of standards committees and key policy initiatives including: MHRA’s Beyond Compliance steering group; the Network of Orthopaedic Registries of Europe; and the ISO Technical Committees for surgical implants and for biological and clinical evaluation of medical devices.
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