Learn the requirements of ISO 13485:2016 and how to implement a Medical Device Quality Management System.

Learn the requirements of ISO 13485 and how to relate the requirements to your business management system. This ISO 13485 Executive Overview Training addresses how management systems (MS) conforming to ISO 13485 apply to the medical device industry and how to use the system to ensure customer requirements are determined and consistently fulfilled over time.

This ISO 13485 Executive Overview Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management.

Because of our independence, you may bring your particular compliance, process and system concerns to class and the instructor will work to answer your questions as best as possible.

  • Interpret and apply the requirements of ISO 13485:2016
  • Apply ISO 14971
  • Implement regulatory issues with minimal impact upon operations
  • Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
  • Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
  • Determine and communicate the resources necessary for the system to work as planned
  • Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
  • Medical device professionals
  • Professionals from FDA regulated industries
  • Quality professionals
  • ISO Managers/Management Reps
  • Internal Auditors
  • Process owners
  • Systems professionals or people who want to understand how management systems work
  • Improvement Specialists
  • Buyers in FDA regulated industries
  • Leaders/managers/professionals in the Medical Device industry

This class may be run in conjunction with a ISO 13485 Lead Auditor Training Course.

Classes are taught in-house in half day, one day and two days version spending on client objectives and audience. Contact us to determine which version will work best for you.

Students successfully completing QMII’s 2-day ISO 13485 Internal Auditor training course and the TPECS examinations provided in conjunction with this course, receive a Certificate of Attainment for the following Exemplar Global (formerly RABQSA International) knowledge competency units:

MD – Medical Devices Management Systems

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global in the competency units required for certification as a Medical Devices Management Systems Auditor using ISO 13485:2016.

Successful course candidates can use these certifications as earned credit towards other certifications such as ISO 9001, ISO 14001 Auditor and other similar standards under Exemplar Global’s Training Provider & Examiner Certification Scheme (TPECS).