Single Course
Medical Devices
Medical Device Regulation (MDR) MDR Clinical Evaluation
Embark on a comprehensive journey into the world of clinical evaluation under the Medical Device Regulation (MDR) with our intensive one-day training course. Designed to equip participants with the knowledge and skills necessary to navigate the complexities of clinical investigation and post-market surveillance lite, this program covers essential concepts, methodologies, and regulatory requirements.
1 Day
Virtual Class
English
Identifier: 142496542
Course Overview
Who This Course Is For
This course is ideal for regulatory affairs professionals, clinical research associates, medical affairs specialists, quality assurance managers, product development managers, and other stakeholders involved in the clinical evaluation, investigation, and post-market surveillance of medical devices. Whether you’re seeking to deepen your understanding of MDR requirements or enhance your practical skills in clinical assessment and surveillance, this training course is tailored to meet the needs of professionals at all levels of expertise.
About this course
Embark on a comprehensive journey into the world of clinical evaluation under the Medical Device Regulation (MDR) with our intensive one-day training course. Designed to equip participants with the knowledge and skills necessary to navigate the complexities of clinical investigation and post-market surveillance lite, this program covers essential concepts, methodologies, and regulatory requirements. Through interactive lectures, case studies, and practical exercises, attendees will gain insights into conducting robust clinical evaluations, ensuring compliance with MDR guidelines, and optimizing post-market surveillance strategies. Whether you're involved in product development, regulatory affairs, clinical research, or quality management, this course provides invaluable guidance to enhance your proficiency in MDR clinical evaluation practices.
Related courses in Medical Devices
View all
Medical Devices
Introduction to the New EU Medical Device Regulation (MDR) eLearning Course
ISO 13485 – Medical Devices
ISO 13485:2016 Medical Device Lead Auditor (TPECS)- CVILT
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.
ISO 13485 – Medical Devices
ISO 13485:2016 Medical Device Requirements (TPECS)
This course is designed to provide participants with a thorough understanding of the ISO 13485:2016 standard, which specifies requirements for a quality management system (QMS) for the design and manufacture of medical devices. Participants will gain detailed insights into the structure and key requirements of ISO 13485:2016, understanding how to implement and maintain an effective QMS in a medical device manufacturing environment. The course blends formal instruction with practical exercises and discussions, ensuring a robust understanding of the standard and its application. 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 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.