IRC was founded in 2004 by Charlie Mack and Elvis Ge.
Charlie Mack worked at UL as a qualified 510(k) reviewer. Trained engineers for Third Party review for Biocompatibility, sterility, software, test documentation, validation and procedures. Has worked with numerous clients in resolving technical issues to ensure FDA and Safety Compliance. Qualified by Cameron Quality associated for IEC 61950, IEC 61010 and IEC 60601-1. Has conducted seminars to assist clients in understanding the Medical Device regulations.
Elvis Ge has worked for Minolta as a QA Manager, Draeger as a Management Representative, UL as a Senior Account Manager and IRC as the Operations Manager.
Biocompatibility Test Center of Medical Devices
Sanitation & Environment Technology Institute Soochow University
Tel: 86-512-65880038, 65880245, 65880240