ISO 13485:2016 Medical Devices Awareness Training Course

The aim of this course is to provide learners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR) as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.COURSE CRITERIAUPON COMPLETION OF THIS COURSE, LEARNERS WILL BE ABLE TO:Identify the links between ISO 13485:2016 (QMS) and MDR EU/2017/745;Explain how terminology has changed and where gaps require additional work for Clients to meet the new requirements;Define new requirements for proactive post-market surveillance;Outline the stages of the transition from MDD to MDR so that clients can create individual transition plans;Define the key deliverables for all economic operators.Learners will need to demonstrate acceptable performance in these areas in order to complete the course successfully.PRIOR KNOWLEDGEBefore starting this course, Learners must have a good understanding of the:Current Medical Directives;ISO 13485:2016;Terminology used; andRequirements to achieve certification.

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.