- What is the difference between a Notified Body and a Registrar?
- What should we consider during our search?
- What should we consider when reviewing proposals from Notified Bodies?
- What are reasons we might need to switch Notified Bodies?
- What are the logistics of switching Notified Bodies?
We answer all these questions and more in this 5-page white paper.
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.