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Ensuring IVD Success: Insights on latest MDCG Guidance, Technical Documentation, and Audit Challenges

April 14 @ 6:00 pm - April 17 @ 8:00 pm

Date: Thursday | April 17, 2025

Time: 6 pm to 8 pm PT

Location: Alcon Laboratories, 20511 Lake Forest Dr, Lake Forest, CA 92630

Registration: New Price! Free for OCRA-DG members; $20 for nonmembers

Topic: Ensuring IVD Success: Insights on the latest MDCG Guidance, Technical Documentation, and Audit Challenges

Learning Objectives:

 1. Understand the EU IVDR requirements

 2. Identify the differences between IVDD and IVDR

 3. Identify potential gaps in technical documentation and management systems

 4. Understand the meaning of the latest MDCG guidances 

Speaker:

Dr. Julien Senac, Senior Director – Medical and Health Services Americas at TUV SUD

Dr. Julien Senac is currently Senior Director of Medical and Health Services at TÜV SÜD America, overlooking certification and testing services for medical devices manufacturers. Prior to this, he has many years of experience with quality and regulatory affairs, through various notified bodies, where he participated to the implementation of IVDR, performed Design Dossier assessment of in vitro diagnostic devices and high risk cardiovascular medical devices. 
Dr. Senac has a Ph.D. in Molecular and Human Genetics and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr. Senac has also participated  to the development of multiple biotechstart-up companies in oncology and gene therapy.

Refreshments and beverages will be provided! Don’t miss out—two raffle tickets will be up for grabs for the 2025 OCRA Annual Conference!

Register now to secure your spot and empower your team for success!

 

 

Details

Start:
April 14 @ 6:00 pm
End:
April 17 @ 8:00 pm
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Venue

Alcon Laboratories
20511 Lake Forest Dr
Lake Forest, CA 92630 + Google Map