EU MDR Auditor Training for the European Medical Device Regulation (2017/745)

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 1^st, 2nd and 3^rd 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

CQI & IRCA certify this course (No. 2696). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.

Prior to attending this course, learners are expected to have the following prior knowledge:

EU MDR

• A good understanding of the EU MDR (2017/745) requirements and their application is required for this course. This may be gained by successfully completing CQI and IRCA Certified MD-QMS Comprehensive EU-MDR 2017/745 Practitioner (PT219) course. A copy of the training certificate will be requested for verification purposes as part of acceptance onto the course.

Please note: if no recognized certificate is provided, additional information & a pre-course test may be required to verify knowledge of the requirements in order to be accepted onto the course.

ISO 13485

• Must have successfully completed a CQI and IRCA Certified MD-QMS ISO 13485 Lead Auditor course or equivalent. A copy of the training certificate will be requested for verification purposes as part of acceptance onto the course.

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.