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 Systems

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.