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 needs smart ideas to reach the right level to pass the quality management audits and technical documentation audits and review by your notified body.
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:
CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of
who work with European Union
Senior Expert Medical Devices, Frank Stein healthcare projects
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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