• In-Depth Understanding: Gain insights into the additional requirements of the Medical Device Regulation (EU), existing directives, and ISO 13485. Understand terminology nuances and certification prerequisites.

  • Course Objectives: Learn to establish links between EN ISO 13485:2016 (QMS) and MDR EU/2017/745. Grasp changes in terminology, identify gaps in compliance, and define new proactive post-market surveillance requirements.

  • Smooth Transition: Outline the stages of transitioning from MDD to MDR, enabling clients to create customized transition plans.

  • Strategic Insights: Define crucial deliverables for all economic operators, ensuring comprehensive knowledge of key responsibilities in compliance with the Medical Device Regulation.

For detailed information on our Medical Device Regulation (EU) Implementation Course, fill in the form to enhance your regulatory expertise.

Medical Device Regulation (EU) Implementation Course

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