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.

Objetives:

• 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;
• Learn on the interpretation of the new requirements.

Audience

Auditors, consultants, healthcare professionals, people responsible for regulatory compliance, quality management, clinical evaluation or risk management related to medical devices.

How the knowledge is tested:

To unlock each module, the participants will have the opportunity to test their knowledge by taking a short quiz.

If they score more than 75% they will be eligible to enrol in the next module.

At the end of the course, the participants will have to take a final test to obtain their training certificate.