ISO 13485 – Medical Devices courses

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.

This training introduces you to management responsibilities under ISO Management System Standards.COURSE CONTENTOverview of ISO Standards, Annex SL standardization, and the PDCA process for continual improvement.Key management responsibilities in Clause 5 (Leadership) and Clause 9 (Performance Evaluation).COURSE CERTIFICATION:On completion of this course:The SGS certificate is available to download once you have achieved a pass mark of 80% or more in the final assessment which completes this course.You have 12 months access to this course, effective from the date of purchase.

This eLearning course aims to familiarise you with the auditing management systems guidelines in accordance with ISO 19011:2018.