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

★★★★★

Overview

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 Snapshot

  • Course Duration:

    24 Hours
  • Format

    Blended Course (7hrs Online & Self-Paced + 2-days Virtual Classroom)
  • Accreditation

    CQI and IRCA approved training partner
    Comply Guru Certified Course
  • 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)
  • Price

    Not Yet Available
  • Fee Includes

    • Comprehensive Course Manual
    • Virtual Instructor Assistance – Phone & Email Support (Online Modules)
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Finally, an industry-leading online, blended & virtual training solution for compliance and certification!

Comply Guru™ offers a library of online, virtual & blended compliance training courses to enable its Learners to get the knowledge and skills they need, from the same systems and devices they use every day

Start DateLocationCostDurationOnsite/Virtual Classroom
Anytime

Anywhere

-
7 Hours (Online & Self-Paced) + 2 Days (Virtual Classroom)
Prior to attending this course learners are expected to have the following prior knowledge: ISO 13485
  • Must be have successfully completed a CQI & IRCA Certified ISO 13485:2016 Lead Auditor course or equivalent
EU MDR
  • 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.
Management systems audit
  • 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.
Medical device management systems Knowledge of the following quality management principles and concepts:
  • 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.
Important Note: The course examination may ask questions that relate to prior knowledge that will not be covered in this course.

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The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 97%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 96%

    Would Recommend Online or Blended Training over Classroom Training

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