ISO 13485:2016 Requirements (TPECS)

BSI America
Training overview
Professional Course
2 days
From 1,295 USD
Start dates
1,295 USD

1,295 USD

San Jose
1,295 USD

1,295 USD

Course description

ISO 13485:2016 Requirements (TPECS)

BSI's “ISO 13485:2016 Requirements” competency-based 2-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and how the requirements impact the day-to-day operations of organizations in the Medical Device industry. An experienced instructor explains the clauses of ISO 13485:2016 in detail, providing a base for understanding the Medical Device Principles and includes auditing the requirements of the standard. Students learn by participating in group exercises and in-depth discussions.

This course covers Exemplar Global TPECS MD - Medical Device Systems Competency Unit whose outcomes are certified by Exemplar Global. Attendees successfully completing this course receive a Certificate of Attainment for this Exemplar Global Competency Unit.

Virtual delivery options may also be available for this course. Get in touch to learn more!

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COVID-19 Update

In light of COVID-19, this provider is now delivering some or all of their courses online. Contact them for more information!

Who should attend?

Who Should Attend

  • Any individual requiring a working knowledge and understanding of ISO 13485:2016 standard
  • Medical Professionals/Consultants
  • Presidents/Vice Presidents/CEOs
  • ISO Coordinators/Management Representatives
  • Engineers
  • Supervisors
  • Laboratory quality professionals
  • Accredited auditors requiring the competency to audit Medical Device Systems


A prior review of the ISO 13485:2016 standard is suggested for this course. 

Training content

Learning Objectives

  • Understand the requirements of the ISO 13485:2016 standard
  • Learn the fundamentals of Quality Management Systems, ISO 9000 / 13485 Standards
  • Auditing to requirements
  • How to identify nonconformities
  • Purpose and content of an audit report
  • Understand Medical Device Regulatory Requirements compliance framework

Course Materials

Students receive comprehensive course manuals with reference materials.

Continuing studies

Attendees who successfully complete the course will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:

  • MD –Medical Device Systems

Continuing Education Units: 1.6.

Why choose BSI?

Leading provider of business improvement solutions

Base of 65,000+ clients across the globe

Training services available in 150+ countries

About BSI


BSI America

With 58 offices serving over 65,000 clients across 150 countries, BSI is a leading global provider of business improvement solutions and training for organizations looking to embed excellence into their daily routines. Through local offices based in the US, BSI...

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