Dasun Abey has solid industry experience in regulatory affairs with a focus on high-risk devices, including orthopedic implants and active devices. Dasun’s background includes authoring multiple CERs to MEDDEV 2.7/1 Rev 4; several 510(k) submissions and EU Technical Files/Design Dossiers; supplier auditing as well as registrations and listings of products in several global markets including the US, EU, Australia and Israel. Prior to joining Emergo, Dasun held RA positions at Fineheart SA, Cellnovo SA and Signature Orthopaedics.