FREE ON-DEMAND WEBINAR
Medical Devices Risk Management according to ISO 14971:2019
During this webinar, the process of risk management according to ISO 14971:2019 is explained, highlighting the changes compared to the old version of the standard.
- Medical Devices
Description
Risk management is an essential process during the development of medical devices.
During this webinar, the process of risk management according to ISO 14971:2019 is explained, highlighting the changes compared to the old version of the standard.
You will learn how to build a risk management file for your product and how this interacts with other processes of product development, incl. Clinical Evaluation, Post-Market Surveillance, …
After this webinar you will:
- understand the risk management process according to ISO 14971:2019
- understand the changes compared to the old version of ISO 14971:2019
- learn how to build a risk management file
- understand the interactions of Risk Management with other processes of product development and quality management
Speaker
Annelies Rotthier, Ph.D.
Annelies Rotthier is a senior IVD consultant. After her Ph.D. in Molecular Genetics at the VIB Institute in Antwerp, she pursued her career in the field of molecular genetics as R&D manager in the spin-off company Multiplicom and later as Director Product Development at Agilent Technologies, a major player in Next Generation Sequencing IVD applications.
She brings her experience to support companies with product development in compliance with IVD Regulation and with the transition to the new IVD Regulation. Risk management activities in accordance with ISO14971 is one of her main expertise.