Torsten Kneuss, Bayer, Germany
The monitoring of how a medical device, respectively, a combination product performs on the market, is a vital component of the lifecycle. A Post-Market Surveillance system implemented helps not only to comply with specific regulations but also supports to improve the quality of the products. It helps to get an understanding of the product, about the safety and performance of the product, and helps to avoid critical issues by early identification of problems. Also, Post-Market Surveillance helps to have an eye on the market and how it further develops related to changes that might impact the use of the product.
This Webinar provides an introduction to Post-Market Surveillance and to the technical report ISO TR 20416, which provides additional background information, especially for medical device manufacturers.
All people involved in Post-Market Surveillance for Medical Devices and Combination Products, e.g., staff in Quality Assurance, Vigilance, Supplier Management, as well as people engaged in Audits and Inspections.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Participants get an understanding of:
- the purpose and process of Post-Market Surveillance
- for which product types this process needs to be applied
- which elements the Post-Market Surveillance consists of
- how the ISO TR 20416 helps to implement a Post-Market Surveillance process in compliance with the (EU) MDR 2017/745