Amie Smirthwaite
Independent Consultant, UK
Amie Smirthwaite is a clinical and regulatory affairs expert with over 30 years’ postdoctoral experience in medical devices spanning new product development, quality and regulatory systems, and clinical evidence. She has been involved in the development of several MDCG and other clinical evaluation guidance documents and has served on numerous advisory board positions, including CORE-MD, HEU-EFS, and NORE, amongst others. She is an active participant in several ISO committees relating to medical device clinical and technical evidence, and is Chair of the Education Committee for ICEPS (International Clinical Evidence Professionals Society). She currently works as an independent consultant advising on clinical and regulatory affairs, but previously worked for BSI, where she was Global Head of Clinical Compliance. Amie was BSI’s first Head of Clinical Compliance, building their clinical compliance team and leading the development of their clinical evaluation processes. She also developed extensive training materials while at BSI, including clinical evaluation, technical documentation, risk management, ISO 13485, EU MDR, and biological evaluation. Amie is a Fellow of the Regulatory Affairs Professional Society.
Danielle Giroud
CEO, MD-Clinicals, Switzerland
With over 30 years of experience within the medical device industry, Ms. Danielle Giroud is founder of MD-Clinicals ( https://www.md-clinicals.com), a purely medical device-focused CRO with offices in Switzerland, Frankfurt, and Beijing.
Ms. Giroud is regarded as an internationally recognized clinical research and regulatory expert, having shared her extensive knowledge and experience with hundreds of multi-national companies, organizations, and start-ups from around the globe to help bring their products to market quickly and efficiently.
She is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (https://www.wmdo.org ), as well as convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155, and liaison with the EU Commission – Clinical Investigation and Evaluation (CIE) task force and other regulatory authorities throughout the world.
