The Summary of Safety and Clinical Performance (SSCP)

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.

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Why Should You Attend:

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:
  • Introduction, who must apply the article 32 EU MDR 745/2017 requirements for summary of safety and clinical performance (SSCP).
  • Smart and fast ways to implement the summary of safety and clinical performance (SSCP) in your quality management system.
  • How to prepare your company regarding summary of safety and clinical performance (SSCP) if you face a quality management system audit or a technical file review?
Areas Covered in the Webinar:
  • How to define a summary of safety and clinical performance (SSCP) process”?
  • How to create the new required reports for the Notified Body and the Competent Authorities?
  • How to do adjustments in the management review
  • How is the summary of safety and clinical performance (SSCP) Process” connected to clinical evaluation, 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, European Economic Area, Switzerland and Turkey

Instructor Profile:
Frank Stein Frank Stein

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.

Refund Policy

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Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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