The Summary of Safety and Clinical Performance (SSCP)

Speaker

Instructor: Frank Stein
Product ID: 706889

Location
  • Duration: 90 Min
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.
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info. Webinar All Access Pass Subscription

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

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

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.

Follow us :

 

 

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).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method