EU MDR Internal Auditor Training



2 days


Virtual Learning




2 days


Virtual Learning


About This Course

Learn how to prepare for the changes from the MDD to the MDR, including audit program management and how to prepare internal audit plans and address gaps during the audit. This course also focuses on ISO 13485:2016 relative to the EU MDR and how companies can be prepared.

This instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the European Medical Device Regulation (EU MDR). The course describes the regulation in depth from the auditor’s perspective and provides practical instruction for planning and conducting audits.

This course includes a two-hour eLearning prerequisite module, EU MDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.

Key Learning Objectives

On completion of this EU MDR internal auditor course, you will be able to:

  • Plan and conduct internal and supplier audits against the requirements of the EU MDR 2017-745
  • Identify conformity and non-conformity against the specific articles and annexes of the regulation
  • Describe correspondence between the EU MDR, ISO13485:2016 and a typical medical device manufacturer’s QMS
  • Select appropriate samples of audit evidence to determine compliance
  • Recognize the primary elements of the European Medical Devices Regulation 2017/745 (EU MDR)
  • Recognize specific requirements relative to manufacturer obligations
  • Identify one strategy for conducting an internal audit against the EU MDR
  • Plan a manufacturer audit against the EU MDR

Who Should Attend

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge to the EU MDR. Students should have some internal audit experience, and ideally have certified auditor/lead auditor qualifications in QMS audits.

Course Tutors

Course tutors can include:

Janet Book - Janet Book has worked in the field of quality for over 35 years in various industries, including blood banking, food processing, quality consulting, chemicals, pharmaceuticals and medical devices, with both large and small companies.

She has conducted internal and supplier audits using many different industry-specific standards and regulations. She also has vast experience writing quality procedures, developing quality management systems, and developing and presenting quality-related training and seminars. Ms. Book is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and a RABQSA Quality Systems Lead Auditor.

Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.

  • "Robert Ruff is such a great teacher. He consistently asked for feedback and encouraged engagement. He was also very considerate of the multi-time zones we were working in.
  • The instructor was awesome and knowledgeable - had a great way of explaining the MDR, with an emphasis on what we as auditors should be looking for as we audit our systems and prepare for external audits.
  • Great collaborations between the instructor and the NSF behind-the-scenes team meant for a very well-run virtual course.
    Rheanna Giardina

Additional Recommended Courses

Medical Device Single Audit Program (MDSAP)

This virtual instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.

This course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.

This course pairs well as a prerequisite to MDSAP Internal Auditor Training (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Discuss the Medical Device Single Audit Program (MDSAP)
  • Evaluate the MDSAP Quality Management System (QMS) audit nonconformity grading system and recognize grades that may trigger regulatory follow-up
  • Identify the IMDRF MDSAP requirements and documents in use
  • Explain the MDSAP Audit Approach

Price: $800.00

CAPA Considerations: Problem Statement Writing and Investigation Techniques

Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners

with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms. 

This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Define the purpose of Corrective and Preventive Action (CAPA)
  • Identify and analyze data inputs for CAPA
  • Compose a proper and complete problem statement
  • Apply investigation techniques to identify root causes and define the appropriate corrective action
  • Identify effectiveness criteria and perform an effectiveness check
  • Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.

Price: $1200.00

CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many ​experienced ​auditors ​decades ​to ​develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. ​During ​the ​course, ​learners ​will ​plan, perform, ​and ​report ​audits ​based ​on ​case ​studies ​that ​simulate ​internal, ​supplier, ​and ​third-party ​audits ​utilizing ​MDSAP ​audit criteria. ​Learners ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning and performing audit activities, ​evaluating ​audit ​evidence, and documenting audit findings.

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).

Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

By the end of this course you should be able to:

· Describe the purpose of:

  • Quality management systems
  • Quality management system standards
  • Management system audits
  • Third-party certification

· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018

· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.

Price: $2800.00