The Summary of Safety and Clinical Performance (SSCP)
Instructor:
Frank Stein
Product ID: 706889
- Duration: 90 Min
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
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
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
