Testing and Compliance of IVD Products

Meet Safety/Performance Requirements of IvD Devices

From May 26, 2022, new IVD medical devices will have to meet the requirements of the IVDR to be placed in the European market. The complex development process for IVD medical devices, combined with the anticipated changes, can be complicated and time-consuming for most manufacturers. 

In this webinar, our expert, Dr. Julien Senac, discusses the standards and testing activities that must be performed to meet the safety and performance requirements of IVD devices. The expert will also provide key steps on how to plan for a less complex transition.

Complete the form to view the on-demand webinar.

Download the Webinar to Learn about:

• Medical device packaging standards, including ISO 11607-1 and ASTM F1980
• Electrical safety standards for medical equipment, such as IEC 61010-2-010, IEC 61010-2-020,
  IEC 61010-2-101, and IEC 61010-2-051
• The medical device software lifecycle process and IEC 62304
• Cybersecurity requirements under the IVDR
• Medical device cybersecurity standards, including IEC 81001-5-1 and UL 2900-2-1

About the Speaker

Dr. Julien Senac

Global Director of IVD Focus Team, TÜV SÜD

Dr. Julien Senac is the Global Director of the IVD Focus Team at TÜV SÜD. He has many years of experience with a certification body, where he participated in the preparation of IVDR designation and performed Design Dossier assessment of in vitro diagnostic devices. Dr. Senac has a Ph.D. in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than ten 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 in developing multiple biotech start-up companies.