Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.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
who work with European Union
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
Areas Covered in the Seminar:
- 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?
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:
Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Prof. Dr. h.c. Frank Stein, Senior Medical Device Expert, Nemius Consulting GmbH
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
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TIME: 10:00 AM - 6:00 PM EST
Venue
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