This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Amie Smirthwaite
Senior Director - Global Clinical Practice at Maetrics

Profile


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 and 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.


Amie has also been a member of the following standards committees and key policy initiatives:

  • ISO Technical Committee ISO/TC 194 (including ISO 14155), Biological and clinical evaluation of medical devices;
  • ISO Technical Committee ISO/TC 150, Implants for Surgery (SC1, 4 and 5);
  • EU Commission Working Group for Clinical Investigations and Evaluations;
  • EU Commission Working Group for Post Market Surveillance and Vigilance;
  • Network of Orthopaedic Registries of Europe, Steering Group;
  • COHESIVE Study Steering Group;
  • MHRA Beyond Compliance Steering Group;
  • Training provided to other Notified Bodies on behalf of Team NB;
  • Clinical evaluation and risk management training provided on behalf of RAPS and TOPRA.


Agenda Sessions

  • Sufficient Clinical Evidence for legacy devices under MDR

    11:05