EU MDR Auditor Training to provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.
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EU MDR Auditor Training
Our Blended Learning Methodology is a hybrid of highly interactive eLearning theory modules that are completed first before attending skills-based Live Instructor Workshops that focus on practical application in a real life context.
Face to Face Learning
On completion of this course, successful Learners will have the knowledge needed to:
- Explain the background and purpose of a medical device quality management system (MD-QMS) in the context of EU MDR 2017/745 and confirm links with ISO 13485.
- Explain the role and responsibilities of an auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 19011/ISO 17021 that uses the EU MDR 2017/745 requirements as the audit criteria.
- Plan for and conduct an audit of a medical device quality management system to establish compliance with the EU MDR 2017/745 in accordance with ISO 19011/ISO 17021 as applicable and report on any nonconformities.
A summary of learning topics within this course include:
- The Role of ISO 13485 in achieving EU MDR compliance
- The Role of ISO 14971 in EU MDR compliance
- Economic Operators in the EU MDR
- The relationship between Harmonized Standards and Common Specifications
- Competency Requirements for the Person Responsible for Regulatory Compliance (PRRC)
- Key General Safety Performance Requirements (GSPRs)
- Key Technical Documentation required under the EU MDR
- Unique Device Identification (UDI) and EUDAMED
- Importance of Post-Market Surveillance and Vigilance under the EU MDR
- Roles of 1st, 2nd and 3rd party Notified Bodies, and Regulatory Audits in EU MDR compliance
- Audit Process for MD-QMS Audits under ISO 13485
- Audit Objectives, Scope and Criteria
- Audit Team Selection
- Audit Methods including surveillance audits, re-audits, special and unannounced audits
- Conducting Onsite Audits
- Audit Frequency
- Auditing the MD-QMS against the EU-MDR 2017/745 Criteria
- Generating Audit Findings
- Audit Reporting
- Corrective Action
- Regulatory Body Reporting
Exemplar Global certify this course under the Recognized Training Provider scheme. Successful completion of this course will entitle the Learner to a digital Certificate of Achievement.
Prior to attending this course, learners must be informed that they are expected to have the following prior knowledge:
- A good understanding of the EU MDR (2017/745) requirements and their application. This may be gained by successfully completing CQI and IRCA Certified MD-QMS Comprehensive EU-MDR 2017/745 Practitioner (PT219) course.
- Must have successfully completed a CQI and IRCA Certified MD-QMS ISO 13485 Lead Auditor course or equivalent.
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- The process approach used in quality management.
- A working knowledge of risk-management principles related to the design of a medical device, through ISO 14971.
To successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for.
- Fully attend the Instructor Workshops as 100% attendance is required.
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
- Pass the end of course final assessment.
For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Gain an Accredited EU MDR Auditor Qualification
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