EU MDR Internal Auditor Training

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.

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.

Brian Ludovico — Brian Ludovico brings over 30 years of experience in the medical device industry including quality management systems, manufacturing processes, and global regulatory compliance. As a former regulator of an industry-leading notified body, he managed the certification department and collaborated with the participating jurisdictional governments in the development of the Medical Device Single Audit Program (MDSAP). As an international quality and regulatory expert, he has conducted hundreds of audits and device technical reviews of medical device design and manufacturing. He has managed corporate auditing and supplier assessment programs, as well as created a corrective and preventive action (CAPA) academy training and qualification. He is appointed as an IRCA-qualified trainer of medical device manufacturers for quality management systems, regulatory strategies, risk assessment, and auditing. He was appointed under the FDA’s Accredited Persons and Third-Party Review programs and is a board member of ASQ’s New England Biomedical Discussion Group.

Alexis Williams — Alexis Williams has worked in a variety of Quality and Regulatory Compliance functions for over 30 years with both world-wide and incubator organizations, supporting QMS development and remediation activities, transformational projects, audit/inspection execution and due diligence activities. She has diverse knowledge across global regulatory jurisdictions and a broad product portfolio specializing in Medical Device, IVD Device, Medical Device Software, combination products and IT solutions and services. Passionate about knowledge sharing, she is dedicated to equipping professionals with the skills needed to navigate complex regulatory landscapes. She is a Certified Medical Device Auditor (CMDA) and active Member Leader of the American Society for Quality (ASQ) Great Britain Section Committee, currently fulfilling the roles of Voice of the Customer and Secretary.