EU Medical Device Regulation 2017/745 Auditor (EU MDR) Training
The aim of this course is to provide learners with the knowledge and skills required to perform third-party audits of medical device quality management systems against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021.
More information coming soon!
Course Duration:24 Hours
FormatBlended Course (7hrs Online & Self-Paced + 2-days Virtual Classroom)
Delivery Options & Discounts
- Available as a blended course including virtual classroom
- Available on select public dates & for in-house training for groups of 5+!
- Multi-Person Discount: Book 3, get a 4th Place Free (Same Course & Dates Apply)
PriceNot Yet Available
- Comprehensive Course Manual
- Virtual Instructor Assistance – Phone & Email Support (Online Modules)
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|Start Date||Location||Cost||Duration||Onsite/Virtual Classroom|
| - ||7 Hours (Online & Self-Paced) + 2 Days (Virtual Classroom)|
- Must be have successfully completed a CQI & IRCA Certified ISO 13485:2016 Lead Auditor course or equivalent
- Knowledge of the EU MDR requirements related to economic operators, quality management system requirements, product classification, conformity assessment routes, clinical evaluation, technical documentation, product realization (including UDI), and postmarket surveillance, which may be gained by completing a Foundation on the EU MDR (2017/745) course.
- Knowledge of management systems audit through satisfactory completion of a CQI and IRCA Certified Lead Auditor Training course (or acceptable alternative).
- Important Note: Learners who have not satisfactorily completed a CQI and IRCA Certified Lead Auditor training course (or acceptable alternative) are unlikely to successfully complete this 24-hour course and will first need to complete a certified lead auditor course.
- The Plan, Do, Check, Act (PDCA) cycle
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
- The process approach used in quality management
- A good working knowledge of the EU Medical Device Regulation and its relationship with ISO 13485
- A working knowledge of risk management principles related to the design of a medical device, through ISO 14971.
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