The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 15, 2022 from 10am to 6pm
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: Dec 26, 2021
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.
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.
CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of