Medical Device Regulation (MDR) Overview of the EU MDR

Join us for an intensive two-day training course that offers a comprehensive deep dive into the Medical Device Single Audit Program (MDSAP) from an auditor’s perspective. This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.During this course, participants will be guided through the intricate details of the MDSAP program, including its grading system, timing, and reporting procedures. The training will cover the step-by-step audit process sequence, providing insights into each stage of the audit. Special emphasis will be placed on auditing techniques based on ISO 19011:2018, preparing attendees to apply these methodologies effectively in their audit practices.Participants will also gain a thorough understanding of the various regulations under the MDSAP program, which encompass multiple jurisdictions including the United States, Canada, Brazil, Japan, and Australia. This course will provide an overview of the specific regulatory requirements of each participating country, ensuring that auditors are well-versed in the diverse regulatory landscapes they may encounter.

Embark on a comprehensive journey through the intricacies of post-market surveillance (PMS) requirements outlined in Annex III of the EU Medical Device Regulation (MDR) with our one-day training course. Designed to provide in-depth insights into the regulatory landscape governing post-market surveillance activities, this course equips participants with the knowledge and tools needed to navigate Annex III compliance effectively. From establishing a robust PMS system to conducting trend analysis and implementing corrective actions, participants will explore key concepts and best practices essential for ensuring ongoing compliance with MDR regulations. Through interactive discussions and case studies, attendees will gain practical skills and strategies for managing post-market surveillance activities to enhance product safety and performance while meeting regulatory obligations.

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485:2016 standard and the principles and practices of effective internal auditing according to ISO 19011:2026 guidelines. The course focuses on the application of ISO 13485:2016 requirements to ensure the quality and safety of medical devices, equipping auditors with the necessary skills to evaluate and improve their organization's quality management system. Participants will learn through a mix of formal tutorials, practical exercises, role-playing scenarios, and group discussions. 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 SystemsImportant 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.