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This interview is the first of a two-part series where Susan shares her thoughts on the new ISO 13485:2016 medical quality management system (QMS) standard, and how it impacts manufacturers.

Susan Mecca 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 LR, 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).

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