Online Overview of EU Medical Device Regulation (MDR)
ObjectivesThe Irish Medtech Skillnet is delighted to join Comply Guru™ and Meddev Solutions in bringing to market this exciting new online self-paced general overview of the EU MDR course.
Content includesModule 1:
Introduction to the EU-MDR (Online & Self-Paced)
- History of MD scandals
- Purpose of EU-MDR
- Structure of EU-MDR
- Medical devices covered by EU-MDR
- Key changes introduced by EU-MDR
- Timelines for transition
Placing on the market (Online & Self-Paced)
- Overview of articles 10, 11, 13-15
- Role of the Manufacturer, Authorised Representative, Importer, Distributer and Person Responsible for Regulatory Compliance
- Overview of articles 5, 19, 20
- Brief overview of Classification, Conformity assessment, EU declaration of conformity and CE Marking
Who should attendAnyone interested in a general overview of the EU MDR.
- Anyone working in the Medical Device Industry
- Quality assurance professionals
- Quality Engineers
- Research and design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
QualificationSuccessful completion will entitle each Learner to receive a certificate of completion.
In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination.
No training dates available at the moment.