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The EU MDR requires medical device manufacturers to create technical documentation as a basis for the conformity assessment and thus for the CE marking of a product. This is compiled from all relevant documents from the product life cycle and must be kept up to date throughout this.
The certificate course shows the participants how technical documentation can be systematically, structured and fully structured and how it can be kept up-to-date over the entire product life cycle.
target group
Medical device manufacturers and distributors, suppliers in the areas of approval, regulatory affairs, quality management, development and construction, product management.
Topic overview & dates
09/12/2024
Basics EU-MDR, MPDG, sources, news, workshop basic UDI-DI
09/18/2024
Project management for RA managers - where do I play a role in the development of products? | Documentation of outsourced processes (suppliers)
10/16/2024
Product life cycle: product development, design transfer, production, change management for medical devices
11/13/2024
PMS: Gap analyzes and state of the art, influences on risk management (e.g. in project management, product changes, clinical evaluation)
11/27/2024
Digitization - what options are there for structuring, options for different tools | Deepening of previously entered questions
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After passing the exam, the participants receive a certificate issued by MedicalMountains GmbH.
Notice
Since the certificate course is for participants with advanced knowledge, we recommend attending Module 1 of the “Regulatory Affairs Manager” certificate course in advance.
Funding Opportunity
KONTAKT:
Online
