Prior knowledge of MDR and MD clinical evaluation and investigation required
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.
After these virtual trainings, you are able to understand and apply:
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:
Because of the international (EU) aspect, this English-taught virtual course offers the opportunity to easily participate from other EU countries as well.
MD professionals from the industry (manufacturers, suppliers, subcontractors and stakeholders)
Background on MD clinical evaluation and investigation. Having knowledge of the MDR.
Literature will be provided as preparation for the course.
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