Medical Device Regulation (MDR) Overview of the EU MDR

This comprehensive program covers both pre- and post-market risk assessment strategies, with a special emphasis on software, artificial intelligence (AI), and cybersecurity considerations. Participants will delve into key concepts, methodologies, and tools for identifying, evaluating, and mitigating risks throughout the device lifecycle. Through interactive sessions, case studies, and practical exercises, attendees will gain practical insights and best practices to ensure compliance with MDR requirements while optimizing product safety and effectiveness.

This intensive course is designed to provide participants with an in-depth understanding of the ISO 13485:2016 standard, focusing on the requirements for a medical device quality management system and the skills needed to lead audit teams effectively. The course combines comprehensive theoretical knowledge with practical auditing exercises, role-playing, and group discussions to ensure participants are well-equipped to conduct and lead internal and external audits.SGS North America is certified by Exemplar Global as a training provider. Participants who successfully complete this course and achieve Competency through the course exam will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:MD - Medical Devices Quality Management SystemsAU – Auditing Management SystemsTL – Leading Management Systems Audit TeamsImportant Notes:We recommend that you turn your camera on during the course to enhance engagement and participation.For the course exam, all learners are required to keep their camera on for the entire duration of the exam.Please bring a valid photo ID (e.g., driver’s license, passport, or work badge) to class for identity verification purposes prior to the exam.Enrollment and attendance in this course indicate participant agreement for SGS Academy NAM to share enrollment information (e.g., participant name, email address, Competency Units attempted, TPECS examination results, etc.) with Exemplar Global. This information will not be shared with any third party (e.g., employer) without the participant’s written consent, unless required by law.

The purpose of this course is to familiarize learners with an overview of ISO 14971:2019 Medical Devices — Application of risk management to medical devices and the differences between the 2012 and 2019 version.