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Learn the requirements of ISO 13485:2016 while understanding how they relate to your organization. This class addresses how quality management systems (QMS) and ISO 13485 apply to the medical device industry and how to develop a management system that conforms to ISO 13485:2016, ready for certification.

This course 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, software validation and supplier management.

Attendees successfully completing the TPECS examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (formerly RABQSA International) knowledge competency units:

MD – Medical Devices Management Systems

AU - Management Systems Auditing

TL - Leading Management Systems Audit Teams

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 Lead Auditor.

Who should attend?

  • Medical device professionals
  • Professionals from FDA regulated industries
  • Quality professionals
  • Individuals who want to become Exemplar Global (RABQSA) certified lead auditors
  • ISO Managers/Management Reps
  • Auditors (internal, 3rd party, and supplier)
  • 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

You will learn how to:

  • Interpret and apply the requirements of ISO 13485
  • Apply ISO 14971:2007
  • Use the QMS and ISO 13485 to ensure compliance to applicable regulations 
  • Implement regulatory issues with minimal impact upon operations
  • Identify and implement the controls necessary for ensuring the QMS consistently meets requirements 
  • Relate fiduciary concerns to the performance of the QMS
  • 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
  • Communicate the roles and responsibilities within the QMS to the organization
  • Conduct and lead 1st, 2nd and 3rd party audits, particularly on undocumented systems and audit for process effectiveness against measurable objectives
  • Relate the capabilities of the organization to the expectations of customers, top management and shareholders
  • Use the QMS to work proactively and not reactively
  • Use the QMS to manage risk, validate software and manage suppliers
  • Provide confidence to customers on how the organization plans to fulfill its promises
  • This class prepares students to conduct 1st, 2nd and 3rd party audits using ISO 13485.

Course Agenda:


Please click here if you are already a certified lead auditor and want to add QMD to your certification.

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