The New ISO 13485:2016
Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes
This interview is the first of a two-part series where Susan Mecca, LRQA Technical Manager, Medical Devices, shares her thoughts on the new ISO 13485:2016 medical quality management system (QMS) standard, and how it impacts manufacturers.
About Susan Mecca:
Susan has over 25 years’ experience in the medical device and clinical laboratory industries as well as certification body and Notified Body systems. As Technical Manager in the medical device sector at LRQA, Susan is a technical expert for ISO 13485 quality management systems and associated regulatory programs, including the Canadian Medical Devices Conformity Assessment System (CMDCAS), In Vitro Diagnostic Devices Directive (IVDD) CE marking program, and Medical Device Single Audit Program (MDSAP).
She has extensive clinical laboratory testing experience in the areas of infectious diseases; transfusion medicine and blood banking; clinical chemistry; hematology; clinical microscopy and microbiology. Susan holds degrees in biology, medical technology and management, and she is a State of California licensed Clinical Laboratory Scientist and certified Medical Technologist with the American Society for Clinical Pathology.