Keith Morel

VP Regulatory Compliance US

Keith Morel, PhD
VP Regulatory Compliance US

Prior to Qserve, Keith was Senior Director of Global Regulatory Compliance at Accuray, a leading radiotherapy medical device manufacturer, where he was responsible for Inspection Readiness activities, governance, and management of the Quality Management System (for a multi-site, international organization), managing the Internal Audit Program and developing and building the new Regulatory Compliance team (from 3 to 14 staff).

Prior to Accuray, Keith was at one of the European Notified Bodies (KEMA, now DEKRA) for 9 years, where he became expert in European regulatory, quality and clinical requirements having conducted over 200 design dossier/technical file reviews and over 100 audits of all types. While at DEKRA, Keith was qualified as both a cardiovascular product expert (head of group), as well as a medicinal substance-medical device combination product expert, and led the review for the first bioresorbable drug eluting stent, and was a review panel member for both the first minimally invasive aortic valve replacement and first percutaneous mitral valve repair therapy, to achieve CE Mark in Europe.

Keith has experience and competence with a large range of devices (Wound care, Vascular, (active) implants, combination devices, IVUS)

 

Want more information? Get in touch with us

Information request