How to fill the gaps of clinical evidence to comply with the Medical Device Regulation (EU) MDR 2017/745
In-company training in CE, PMS and PMCF (NL - EN)
Prior knowledge of MDR and MD clinical evaluation and investigation required
Learn how to perform a gap analysis on the clinical evidence
The MDR rules out stricter requirements for clinical data, and its acceptability as clinical evidence needs to be analyzed, specified and justified.
Currently the MDR requires MD companies to comply with strict requirements when performing Clinical Evaluations, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).
During this online training all above will be explained in order for the participants to understand the clinical needs, and to analyze and fill the gaps in clinical evidence.
Resultaten
Objectives
After these virtual trainings, you are able to understand and apply:
- Fully understand how the MDR has an impact on clinical requirements.
- Understand the need for well-planned and -established CE, PMS & PMCF.
- Analyze gaps in clinical evidence & know how these gaps can be filled.
Programma
Program
This live online training is divided into two sessions of three hours each in which the expert theory alternates with interactive discussions and cases. Following topics are covered:
- The impact of the MDR on clinical requirements
- Clinical Evaluation, PMS & PMCF activities
- What is Clinical data & Clinical evidence?
- How to perform a gap analysis?
Because of the international (EU) aspect, this English-taught virtual course offers the opportunity to easily participate from other EU countries as well.
Doelgroep
Target audience
MD professionals from the industry (manufacturers, suppliers, subcontractors and stakeholders)
- Clinical Affairs
- Regulatory Affairs
- Quality Managers
- Clinical Project Managers
Prior knowledge
Background on MD clinical evaluation and investigation. Having knowledge of the MDR.
Literature will be provided as preparation for the course.
Jouw coaches
Praktische informatie
Annulatievoorwaarden
Voor bedrijfsinterne projecten verwijzen we naar de algemene voorwaarden en de voorwaarden in de aangeboden offerte.
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oplossingen
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