How to Select and Change a Notified Body in Europe

About the Author

Jaap Laufer, MD, PharmD is Vice President of Regulatory & Clinical Affairs at Emergo. Dr. Laufer has over 30 years of experience in the medical device and pharmaceuticals industries. He previously held executive and senior regulatory positions at Pfizer, Abbott Laboratories, LipoMatrix, and others. His areas of expertise include a vast array of mostly implant and higher classed products, ISO and FDA QSR audits, and clinical study approvals and compliance. He holds a PharmD in Pharmacy from the University of Groningen and is an MD from the Medical School of the University of Nijmegen, both in The Netherlands. Dr. Laufer is a member of the Medical Devices Expert Group to the EU Commission and teaches at the University of Southern California in Los Angeles, USA.