Medical Device Regulation (MDR) MDR Clinical Evaluation

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.

Day 1: Overview of the EU MDRJoin us for a comprehensive one-day training course providing an in-depth overview of the European Medical Device Regulation (EU MDR). Designed to equip medical device professionals with essential knowledge, this course covers key aspects of the EU MDR, including regulatory requirements, compliance strategies, and implementation challenges. Through engaging presentations, case studies, and discussions, participants will gain insights into the changes introduced by the EU MDR and learn how to navigate the regulatory landscape effectively.Day 2: MDR Risk Management: Pre and Post MarketThis dynamic one-day training course focuses on mastering risk management under the MDR, covering both pre- and post-market risk assessment strategies. Special emphasis is placed on software, artificial intelligence (AI), and cybersecurity considerations. Participants will learn key concepts, methodologies, and tools for identifying, evaluating, and mitigating risks throughout the device lifecycle. Through interactive sessions and practical exercises, attendees will gain insights into ensuring compliance with MDR requirements while optimizing product safety and effectiveness.Day 3: MDR Clinical EvaluationThis intensive one-day training course provides comprehensive knowledge and skills for navigating clinical evaluation under the MDR. The program covers essential concepts, methodologies, and regulatory requirements for clinical investigation and post-market surveillance. Through interactive lectures, case studies, and exercises, attendees will learn how to conduct robust clinical evaluations, ensure compliance with MDR guidelines, and optimize post-market surveillance strategies. This course is ideal for those involved in product development, regulatory affairs, clinical research, or quality management.Day 4: MDR Documentation RequirementsThis comprehensive one-day training course focuses on the essential documentation requirements mandated by the MDR to ensure regulatory compliance and facilitate market access for medical devices. Participants will learn how to create, manage, and maintain documentation that adheres to MDR standards. The course covers the full spectrum of required documentation, including technical documentation, clinical evaluation reports, and post-market surveillance plans. Through interactive sessions and practical exercises, attendees will gain the knowledge and tools to navigate MDR documentation requirements confidently.Day 5: MDR Post Market Surveillance Requirements This one-day training course provides in-depth insights into the post-market surveillance (PMS) requirements outlined in Annex III of the MDR. Participants will learn how to establish a robust PMS system, conduct trend analysis, and implement corrective actions. Through interactive discussions and case studies, attendees will explore key concepts and best practices for managing post-market surveillance activities. This course equips participants with practical skills and strategies to enhance product safety and performance while meeting regulatory obligations."