MedicalMountains GmbH The EU-MDR from a developer perspective - the compliant development process

content

DIN EN ISO 13485:2016 and the EU-MDR place high demands on the development process for medical technology products. The focus is on the safety and performance of the products and their evaluation within the framework of risk management and clinical evidence.
In the seminar, the normative and regulatory requirements are discussed in detail and techniques are taught that illuminate all essential aspects of the process, from planning to evaluation of the development results and their transfer to production.

The contents of the seminar are conveyed to the participants in a practical and clear manner using examples and exercises.

topic overview

• The planned development process (development phases) according to DIN EN ISO 13485:2016 and EU-MDR
• Evaluation of the development results (incl. verification and validation)
• Transfer of development to manufacturing
• Risk management as part of the development process
• The clinical evaluation in the context of product development
• Elements of product development as part of the technical product file

target group

Employees from the areas of development, marketing/product management and quality management.

previous knowledge

Basic knowledge of DIN EN ISO 13485:2016 and the EU-MDR.

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