How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV?

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 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.

Who will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

• medical device manufacturer
• importer
• distributors and
• dealers