Maetrics appoints Dr. Amie Smirthwaite to lead Clinical Practice
May 2020 – Maetrics, an international leader in life sciences quality and regulatory consulting, has appointed Dr Amie Smirthwaite as Senior Director of the Global Clinical Practice. A clinical and regulatory affairs expert, Amie has over 25 years’ postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems and clinical data evaluation. She will be leading the company’s global clinical practice discipline which is dedicated to delivering effective clinical and performance evidence and post-market surveillance for international medical device and IVD regulatory compliance.
Prior to joining Maetrics, Amie was the Global Head of Clinical Compliance at BSI Notified Body, 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.
The Clinical Practice at Maetrics was developed in response to the growing regulatory and quality requirements for clinical and performance evidence. Maetrics offers a managed service which oversees and maintains the entire life cycle of clinical and performance data across the critical regulatory and quality updates and inputs that are required, including: pre-market, post-market surveillance, risk management, tech file updates, notified body reviews.
Steve Cottrell, President at Maetrics, comments: “With increasing pressure on regulatory teams to meet new and growing requirements for clinical and performance reporting, finding a partner that delivers effective clinical compliance services is now critical for manufacturers who want to focus on their organizational goals and deliver business success in the long-run. We are delighted to welcome Amie to the Maetrics team. Her hands on Notified Body experience and the EU MDR expertise she brings means that Maetrics will continue to lead the charge in its clinical managed services.”
Amie adds: “I am thrilled to be starting this new journey with Maetrics, and to lead such a high-calibre team in the Clinical Practice. With an additional year to work on EU MDR compliance and two years to go until the EU IVDR deadline, we are dedicated to supporting life science companies as they navigate uncharted waters.”
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