Dublin, Dec. 29, 2021 (GLOBE NEWSWIRE) -- The "How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV?" training has been added to ResearchAndMarkets.com's offering.
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements.
One hot topic is the focus on the clinical data, "Clinical Evaluation-Process" and the new requirements and how this process is connected to other processes in the quality management system according to ISO 13485:2016 and EU MDR 2017/745. The understanding of this changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.
Why You Should Attend:
You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system and your technical documentation. Your implementation timeline until May 2021 is short and need smart ideas to reach the right level to pass the quality management audit and technical documentation audit and review by your notified body.
Learning Objectives:
- Introduction, who must apply the new EU MDR 745/2017 requirements
- Overview about the changes of the EU MDR 745/2017 regarding "clinical evaluation" of your products
- Explaining of each change
- Smart and fast ways to implement the changes in your technical documentation
- Fast track internal audit to approve the changes
Key Topics Covered:
- How to define a "Clinical Evaluation-Process"?
- How to create the new clinical evaluation for the Notified Body and the Competent Authorities?
- How to gather the data input for the clinical evaluation?
- How is the Clinical Evaluation-Process" connected to post market surveillance, customer feedback, complaints and vigilance?
For more information about this training visit https://www.researchandmarkets.com/r/tf33vt
