Interview Part 2: The New ISO 13485:2016
Overview of ISO 13485:2016 (Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes)
Susan Mecca concludes her interview series with what she sees as the single most important change within the new standard as well as:
- Addressing more stages of the product life cycle
- The increase of regulatory requirements
- Global harmonized task force (GHTF) guidance document considerations
- Risk-based approach requirements
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.