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