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
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.
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.
Additional Recommended Courses
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
EU IVDR Internal Auditor Training
This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.
This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR). The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.
This course includes a two-hour eLearning prerequisite module, EU IVDR – 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 pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.
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:
- Identify Key Articles and Annexes of the EU IVDR
- Recognize Intent of Requirements as Described in Recitals
- Identify Classification Implementing and Classification Rules
- Identify General Safety and Performance Requirements (GSPRs)
- Recognize Content of Technical Documentation
- Identify Post-Market Surveillance Reporting and Vigilance Obligations
- Recognize one EU IVDR Audit Model
- Plan an EU IVDR Audit
- Document Nonconformities against EU IVDR requirements
Who should attend:
This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.
Price: $1200.00
ISO 14971:2019 - Risk Management for Medical Devices and IVDs - Practical Application
ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s quality management system.
This virtual instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process including review of TIR 24971:2020.
This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.
This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.
This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (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:
- Identify regulatory requirements for risk management:
- European Regulation EU 2017/745 (EU MDR)
- European Regulation EU 2017/746 (EU IVDR)
- 21 CFR 820.30(g)
- Identify requirements of key International Standards relative to risk management:
- ISO 14971:2019
- ISO 13485:2016
- Recognize risk management definitions and principles
- Identify how risk management affects quality management system practices
- Recognize one method for the practical application of risk management principles
Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge on comprehensive risk management processes and explain their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.
Price: $1200.00