This annual event hosts the global regulatory community and brings together the profession’s best and brightest to learn, grow, lead and share.
Don’t miss LRQA’s presentation:
Tuesday, September 12 2017 at 2:45pm – 3:30pm
Find out what the IVDR & MDR Regulations mean to your organization - LRQA presents the top frequently asked questions.
With the publication of the new IVDR and MDR regulations, regulatory affairs professionals and device manufacturers are seeking clarification on how to implement the new requirements within their organizations. These new regulations tighten and strengthen the approval system and introduce several key changes that manufacturers will need to implement, including:
- Scope of regulated medical devices and IVDs
- Identification and traceability
- Pre-market scrutiny procedure
- Classification and conformity assessment requirements
Join this session and find out answers to the industry’s frequently asked questions for a better understanding of the key changes, impacts, transition phase and steps to be taken.
Speaker: Susan Mecca, Senior Technical Manager, Medical Devices Americas
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.