> medical devices training>Auditing a Medical Devices Quality Management System ISO 13485:2016

SAI Global Assurance Learning is a certified training provider for the following Exemplar Global competency unit(s):

  • Exemplar Global – MD – Medical Devices Management Systems

This 2-day course provides attendees with a thorough insight into Medical Devices Management Systems requirements based on the ISO 13485 Standard.

  • To provide an in-depth review of the requirements of the ISO 13485:2016 standard and how they are applied in the context of an audit
  • To meet the training requirements for the Exemplar Global (TPECS) Auditor Certification Program, Competency Unit MD
  • This course can be taken individually or combined with the Conducting and Leading Medical devices management system audits course to form a four-day lead auditor course, depending on individual objectives
  • Understand the intent and requirements of the ISO 13485:2016 Standard in the context of a quality management system audit
  • Understand the relationship between the applicable regulatory requirements and ISO 13485
  • Explain the concepts of the process approach, Plan-Do-Check-Act, process-based activities and associated inputs, outputs, controls, and resources
  • Understand how to evaluate the effectiveness of an entire quality management system, including process, customer focus and improvement to meet regulatory requirements
  • Evaluate, using risk-based thinking, the effectiveness of an entire quality management system as applied to medical devices
  • Throughout the course a series of activities will provide the opportunity for attendees to demonstrate the knowledge they have gained
  • Studying the current published version of ISO 13485 prior to attending this course is recommended
  • Individuals who want to obtain a formal qualification in the application of Medical Devices to add to their auditing experience
  • Individuals leading their companies to ISO 13485 certification
  • Business Managers, Quality Managers, Engineers, Compliance Officers, and Consultants
  • Individuals who want to become a Certified Medical Device Quality Management Systems Auditor through their relevant certifying body such as Exemplar Global

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SAI Global Assurance Learning is a certified training provider for the following Exemplar Global competency unit(s):

  • Exemplar Global – MD – Medical Devices Management Systems

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