Danielle Giroud

With over 35 years of experience within the medical device and in-vitro diagnostic industry, Ms. Danielle Giroud is founder and CEO of MD-Clinicals (https://www.md-clinicals.com), a purely medical device and in-vitro diagnostic-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) and is a recognised subject matter expert providing extensive training around the world. Since 1998, she has been extensively involved in ISO work and became in 2008 the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and 18969 on clinical evaluation. From her position as a convenor of the TC 194 WG 4 she is a firm believer in regulatory convergence and established the liaison with the EU Commission - Clinical Investigation and Evaluation (CIE)