TO THE POINT
- 30 years of regulatory and clinical experience.
- Serves as Emergo’s Medical Director
- Teaches International Regulatory Affairs at the University of Southern California
- Active Collaborator at the Beall Institute and ULP.
- Member of the Medical Devices Coordination Group
- Has held corporate positions in Regulatory and Clinical Affairs at Lipomatrix, Pfizer, and Abbott Laboratories.
Dr. Jaap Laufer, MD, PhD
Lead Regulatory for EU CE-Mark
Dr. Jaap Laufer has over 30 years of regulatory and clinical experience. He is specialized in implant, high-risk device and combination product submissions, FDA QSR compliance, and clinical study submissions and compliance. As Emergo’s Medical Director, he is an expert reviewer of clinical data and evidence for novel and high-risk devices. In his additional capacity as a senior clinical consultant, he also peer reviews EU clinical evidence submissions and product classification, and assists with Notified Body management. He has attended countless meetings with FDA and Notified Bodies.
Dr. Laufer teaches International Regulatory Affairs at the University of Southern California (USC) in Los Angeles and is an active collaborator at the UCI incubation structure (Beall institute and ULP “wet labs”). He is also a permanent member of the Medical Devices Coordination Group (MDCG) to the European Commission for Classification, formerly the Medical Devices Experts Group (MDEG, since 2005). He is the founder of EMDC, a small company in Europe that specializes in FDA compliance for non-US companies. In 1999 Dr. Laufer established the European Association of Authorized Representatives, a small buwt rather influential trade organization.
He held corporate positions in Regulatory and Clinical Affairs in Switzerland–based Lipomatrix (mammary implants), Pfizer Hospital Products Europe, and Abbott Laboratories (drugs).
Dr. Laufer holds degrees in Pharmacy and Medicine from the University of Groningen, The Netherlands. He published numerous articles in his areas of expertise and has presented at numerous national and international meetings. He is married and has two children, who have their own families in Irvine, CA, and in Tel Aviv, Israel.