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 Recording 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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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