Introduzione
Medical Device Software is a rapidly evolving field in the MedTech industry and requires specific considerations for the Clinical Evaluation Report and the State of the Art Evaluation.
MDCG 2019-11 helps with the specific classification rules for Medical Device Software, whereas MDCG 2020-1 provides recommendations for the clinical evaluation strategy.
However, clinical evaluations for medical software can be less straightforward than for hardware devices.
Participants will get a brief overview of the regulatory framework in the European Union for Medical Device Software. After that, we will take an in-depth look at how to discuss valid clinical association, technical performance, and clinical performance of Medical Device Software in the clinical evaluation.
The workshop will also discuss the challenges of writing State of the Art Evaluations, identifying benchmark parameters, and defining clinical benefits for Medical Device Software.
It will be an interactive training with team exercises and room for questions and discussions.
- Regulatory framework, classification rules, and relevant guidance documents
- Demonstration of valid clinical association
- Demonstration of technical and clinical performance
- Considerations for State of the Art Evaluations for Medical Device Software
- Challenges of identifying meaningful benchmark parameters and clinical benefits
The course is addressed to Clinical or Regulator Affairs Specialists, Medical Writers, or Product Managers.
Participants will learn about the specific considerations for the clinical evaluation for Medical Device Software.
Participant experience
Participants should have a good understanding of clinical evaluations for medical devices and should have experience in writing Clinical Evaluation Reports.
There is no need for experience with Medical Device Software.
Interactive training with a mixture of presentations and group exercises.
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
01 July 2025 from 09:30 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 10 June 2025)
Ordinary: € 610,00*
Freelance – Academy – Public Administration: € 390,00*
* for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Ilaria Butta
Events & Training Manager
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.