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Clinical affairs managers deal with all issues relating to the clinical evaluation and testing of medical devices. The goal is to prove that the medical device is safe to use and provides clinical performance. These parameters must be supported by clinical data and monitored and confirmed over the entire product life cycle. The EU MDR specifies the clinical requirements for placing medical devices on the market in terms of safety and clinical performance.
The certificate course enables graduates to move safely in these subject areas and to initiate and accompany the necessary steps in the company.
target group
Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.
Topic overview & dates
Module 2 details
10/10/2024 The clinical trial at a glance and the connection between the clinical evaluation and the clinical trial
2024-10-24 ISO 14155 - The clinical investigation plan (CIP) - Overview and Declaration of Helsinki
11/06/2024 Roles, tasks and duties in the context of the clinical trial
11/19/2024 Implementation and evaluation of a clinical trial
12/04/2024 Contracting of a clinical trial - legal agreements between sponsor and center
exam and graduation
After each module, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After successfully completing both modules, the participants receive a certificate issued by MedicalMountains GmbH.
Notice
The modules can be booked individually. If these are completed within 2 years, you will receive a certificate. When booking both modules at once, a special price of EUR 5,690.00 is granted. We recommend attending Module 1 of the "Regulatory Affairs Manager" in advance.
You can book the entire course or module 1 via the following links:
Clinical Affairs Manager Module 1
Funding Opportunity
KONTAKT:
Online
