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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.
Depending on an average duration time, this total e-learning part of the course will take you approximately 8 hours.
- 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.
Access to course material augmented with exclusive insights from big data analytics based on our database of millions of audit findings worldwide
Gain 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.
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.