How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV
Instructor:
Frank Stein
Product ID: 706887
Training Level: Intermediate
- Duration: 75 Min
Why Should You Attend:
The medical device regulation EU MDR 745/2017 in the European Union has a lot of requirements. One key topic is the focus on the clinical data, “Clinical Evaluation-Process” and how this process is connected to other processes in the quality management system according to ISO 13485:2021 and EU MDR 2017/745. The understanding of the changes and how to implement the changes is essential to keep your certificates up to date and to keep the market entry open to EU, EEA, Switzerland and Turkey.
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 Webinar:
- 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?
Who Will Benefit:
CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of
- medical device manufacturers
- importer
- distributors
- dealers
who work with European Union
Instructor Profile:
Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects
Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience for 27 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, Brazil.
More Training By Experts
- Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
- ISO 13485:2016 - What are the hot topics and changes?
- Supplier Management with the new Medical Device Regulation EU MDR 745/2017
- Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
- Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
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