MDR Training Course - E-learning (in English)
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. Audience Auditors, consultants, healthcare professionals, people responsible for regulatory compliance, quality management, clinical evaluation or risk management related to medical devices.
Objectives
- derstand the iUnntent 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.
Pre-requisites
Participants must have complete knowledge of the MDD (medical device regulation); the relevant harmonized standards and common specifications; and the MEDDEVs – the guidance documents written by the Competent Authorities.
Audience
Auditors, consultants, healthcare professionals, people responsible for regulatory compliance, quality management, clinical evaluation or risk management related to medical devices.
Objectives
- derstand the iUnntent 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.
Pre-requisites
Participants must have complete knowledge of the MDD (medical device regulation); the relevant harmonized standards and common specifications; and the MEDDEVs – the guidance documents written by the Competent Authorities.
Audience
Auditors, consultants, healthcare professionals, people responsible for regulatory compliance, quality management, clinical evaluation or risk management related to medical devices.