This presentation will talk Medical device legacy software to IEC 62304 including introduction of IEC 62304 overall process, software safety classification, Risk management activities of legacy software, legacy software gap analysis activities, Rationale for use of legacy software, and The levels of changes made to legacy software
Mr. Liem Lam holds Sr. Medical Product Safety Engineer at Nemko USA, Inc. and he is a member of AAMI for Medical product safety and IEEE for Medical product safety and Laser product. Liem has more than 10 years of experience in the field of medical devices compliance and more than 10 years of experience in the field of R&D HW/SW testing electrical and electronics products / systems. Prior Nemko Liem worked at CSA Group, Intertek, TUV SUD, California Instruments, Hewlett Packard and Qualcomm CDMA.
Nemko USA, Inc. 2210 Faraday Ave. Suite 150 Carlsbad, CA 92008