Glen 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 joining the CRO Group, Glen was the Director of the USA operation for TUV 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 M.Eng in Biomedical Engineering, and a BSEE.
Shuzhi is a CRO Group junior regulatory associate. Shuzhi has a B.S. Nursing and a M.S. Regulatory Affairs. She is fluent in Cantonese, English, and Mandarin and joins us from the Shenzhen region of China. Shuzhi supports CRO Group’s clinical study and medical device approval projects.
Bill is a CRO Group medical device and quality system compliance and regulatory expert. Bill has over 15 years experience in this field, preparing 510(k) submissions and international product registrations and has brought dozens of medical device manufacturers through the ISO 13485, CE Mark, and CMDCAS certification process..
Leo is the CRO Group’s active (electrical safety and EMC) medical device and quality system compliance expert. Leonard is the principal of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering. He has 15 years experience in product safety at UL, TUV and Karl Storz. Leonard was the Manager of Compliance Engineering at Karl Storz and Senior Product Safety engineer at TUV Product Service.
Mark is the CRO Group’s implantable and invasive biocompatibility, packaging, and sterilization expert. Mark is the principal of Roberts Consulting and Engineering. He is a certified lead auditor and CE marking and product sterilization expert. He has over 20 years of medical device industry experience. Previously he was the head of western USoperations for T?V Product Service. Prior to that he was Manager of Quality System for Becton Dickinson and Sterility Assurance Manager for Baxter Healthcare, Bentley Division