Introduzione
The Summary of Safety and Clinical Performance (SSCP) is a document that is with a unique structure and format: it is intended to include detailed information on a medical device for both healthcare providers and patients and will be available for the public.
Many manufacturers already know how to write an SSCP.
We also have read MDCG 2019-9, but how can we go from good to excellence? And how can we improve a document which will be public soon?
To be able to work on your SSCP you need strong technical skills. You also have to be able to translate the technical documentation into lay language: Are we complying with a regulatory requirement or are we really communicating with the public?
Consistency with the Technical Documentation, different expectations from the manufacturer and the Notified Body and strict timelines are additional hurdles.
This workshop will navigate you through the needed skills to achieve excellence and positively impact the final document.
- Introduction to Article 32 of EU MDR 2017/745 (Summary of Safety and Clinical Performance)
- Structure and Content: The MDCG (Medical Devices Coordination Group) Guidance 2019/9
- How to optimize input documents for more efficient SSCP writing
- Best practice tips to summarize safety and performance data
- How to improve the patients’ section of the SSCP
The workshop is addressed to Clinical Affairs, Quality Assurance, Product Managers and Medical Writers.
Attendees’ experience
This workshop is intended for personnel with little experience in regulatory writing, including the Summary of Safety and Clinical Performance, under the Medical Devices Regulation 2017/745 (EU MDR) and with little experience in the preparation of lay summaries.
The workshop will be a mixture of presentations, team discussion, brainstorming and practical examples.
Docente/i
Katharina Friedrich
Katharina Friedrich is a medical writer with experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant with focus on orthopedic and cardiovascular devices. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic and trauma surgery.
Online training – 1 module
16 April 2025 from 9:00 am to 1:00 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 480,00* until 26/03/2025
Ordinary: € 610,00*
Freelance – Individual – Academy – Public Administration**: € 390,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: seat at the training, training material, coffee break, organisational office assistance, certificate of attendance.
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
