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Please see the ISO 13485:2016 Medical Devices Introduction and Awareness Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.Running a standard or customised course at your premises allows you to shape the message and style of the presentation to suit the culture of your organisation. It is the most convenient and cost-effective solution if you wish to train a number of staff in the same location, or when confidentiality is an issue. Once we have agreed the dates and location for your training course, our experts work with you to identify and evaluate your learning objectives and to customise the course content to ensure they are metContact Details+44 (0) 1276 697777Website: www.sgs.co.uk/trainingschedule Email: ukacademy@sgs.com

MDIAPlease see the ISO 13485:2016 Medical Devices Internal Auditor - Virtual Instructor-Led Training Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.This course has been prepared by the medical device specialists of SGS and the content approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognised Registrar, UKAS accredited certification body 005, under the FDA Approved Persons Program and is recognised by many other regulatory authorities including those in Australia and Taiwan. Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognised by the Hong Kong Medical Device Control Office.

MDLACPlease see the ISO 13485:2016 Medical Devices Auditor/ Lead Auditor Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.The aim of this course is to provide students with the knowledge and skills required to perform first, second (including supplier) and third party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011.

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.