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.
Additional Course benefits include access to course material augmented with exclusive insights from big data analytics based on our database of millions of audit findings worldwide. Participants will also gain free access to our online self-assessment tool where they can quickly implement and practice learnings as well as to measure company performance against specific management system standards.
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.
Participants must have complete knowledge of the MDD (Medical Device Directive; the relevant harmonized standards and common specifications; and the MEDDEVs – the guidance documents written by the Competent Authorities.
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.
To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Medical devices; or Contact us if you are interested or want to know more on in-house courses.