Medical Device Regulation / Medical Device Directive Comparison eLearning

This eLearning compares the differences between Medical Device Regulation EU 2017/745 & the Medical Device Directive.

A foundation course designed to walk the participants through the key elements and main changes in the Medical Device Regulation EU 2017/745 compared to the Medical Device Directive.

Objective

On successful completion of this course attendees will be able to:

  • Understand the intent of the MDR and its requirements;
  • Identify the key changes compared to the MDD;
  • Define the scope of the regulation and its impact;
  • The interpretation of the new requirements.

Prerequisites

Participants must have knowledge of:

  • the MDD (Medical Device Directive).
  • The relevant harmonized standards and common specifications.
  • The MEDDEVs (guidance documents written by the Competent Authorities).

Audience

This course is intended for auditors, consultants, healthcare professionals, people responsible for regulatory compliance, quality management, clinical evaluation or risk management related to medical devices needing to work to the EU MDR.

All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

Additional benefits include

Access to course material augmented with exclusive insights from big data analytics based on our database of millions of audit findings worldwide

Free access to our online self-assessment tool where you can quickly implement and practice learnings as well as to measure your company performance against specific management system standards

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