EU MDR Internal Auditor Training
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 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.