FREE ON-DEMAND WEBINAR
Building Safe and Effective Medical Devices: A Deep Dive into the Design and Development Process
During this webinar, the process of Design and Development of Medical Devices according to ISO 13485 and applicable regulations will be explained, with practical yet simplified examples to illustrate the main concepts of the process. How to handle changes to Medical Devices will also be explained.
- Medical Devices
Description
Design and development is a central process for manufacturers of medical devices. ISO 13485 introduces some key concepts that are needed for a robust process, in order to ensure that the developed device will be safe and effective.
In this webinar, we will explain what the requirements for this process are, using practical examples to illustrate how they interact with each other and how they all participate in the development of a safe and effective device.
After this webinar you will:
- understand the main requirements of ISO 13485 regarding Design and Development
- understand the role of regulations and other standards in this process
- understand how the post-marketing information is used to improve medical devices.
Speaker
Anne Collard
Anne Collard is a Project Manager at QbD since 2020. After her Ph.D. in Biomedical Engineering at the University of Liège, she progressively switched from D&D of medical devices to Quality Assurance and Regulatory Affairs roles.
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As Project Manager, she supports Medical Devices companies wanting to implement or improve their Quality Management Systems according to ISO 13485 and main international regulations. She is also a certified Lead Auditor for this standard.
Ben Bekaert
Ben Bekaert is a Medical Device Expert at QbD since 2020. He has been a part of product development teams for the past 8 years, working on products ranging from in-vitro diagnostic to implantable devices.
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He has been involved in the research and development of medical devices, as well as the pursuit of regulatory clearance pathways. As a result, he is a co-inventor on multiple pending or upcoming patent applications. He has helped obtain FDA 510(k) clearance for a patient-specific 3D-printed titanium implant system that was the first of its kind to receive such clearance.