Attend this webinar to understand, what are the requirements of article 32 EU MDR 2017/745 for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP). Your implementation needs smart ideas to reach the right level to pass the quality management audit and technical file audit by your notified body or authority inspection.
The 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 summary of safety and clinical performance (SSCP) and the requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according EN ISO 13485:2021. The understanding of these requirements and how to implement into the quality management system and the technical file is essential to keep your certificates up to date and to keep the market entry open.
Learning Objectives:CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of
who work with European Union, European Economic Area, Switzerland and Turkey
Frank SteinSenior 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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