Single Course ISO 13485 – Medical Devices 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.

4 Days Virtual Class English Identifier: 183765966
ISO 13485:2016 Medical Device Lead Auditor (TPECS)- CVILT

Course Overview

What you'll learn

  • Gain a comprehensive understanding of ISO 13485:2016 and its application in the medical device industry.
  • Master the principles and practices of leading quality management system audits in accordance with ISO 19011:2018 and ISO/IEC 17021-1.
  • Develop the skills required to lead an audit team effectively.
  • Learn techniques for planning, executing, reporting, and following up on audits.
  • Understand how to assess compliance with ISO 13485:2016 requirements and drive continuous improvement.

Who This Course Is For

Who Should Attend:

  • Quality managers and professionals in the medical device industry.
  • Internal and external auditors who wish to lead audit teams.
  • Regulatory affairs specialists.
  • Individuals responsible for maintaining and improving the quality management system.
  • Those seeking to enhance their auditing skills and knowledge of ISO 13485:2016

About this course

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 Systems
  • AU – Auditing Management Systems
  • TL – Leading Management Systems Audit Teams

Important 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.

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