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GLEN E. EMELOCK is
the senior partner, and is the CRO Group's clinical investigation, biotechnology and IVD
product, and software/Part 11 expert. He has over 25 years of experience in health care. He
has brought several complex Class II and III medical instruments and systems from drawing
board to production for Millipore Corporation during his 9 years with the company. During
this time, he specialized in international and software regulatory engineering for several
Millipore divisions. Prior to establishing the CRO Group, Glen was the Director of the USA
operation for TÜV Product Service, Medical Division, responsible for implementation of
ISO 9001, ISO 13485, and EU
MDD/IVDD/CE Marking certifications for over 200
medical device manufacturers. Glen has a Master of Engineering in Biomedical Engineering
from Rensselaer Polytechnic Institute, and a B.S.E.E. from Union College.
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