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ISO 13485:2016 Requirements (TPECS)

The class is not currently available.

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.

New to TPECS?

For more information, please see our Understanding the TPECS Course Structure page.

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.

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

Prerequisites

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

Class Logistics

There is a test at the end of Day 2 of this course. Detailed exam instructions will be provided. A Certificate of Attainment in the MD competency unit will be provided for students who are deemed “Competent” for the MD competency unit. Certificates of attendance are provided to those who do not pass the competency test, and students will be given the opportunity to retake the test.

Online course option

This Course is also available as part of BSI’s Connected Learning Live service. A virtual instructor lead training course taught live online in a virtual classroom. Scheduled times and dates are available HERE

Upcoming Course Dates

The venues for scheduled courses are tentative until receipt of course confirmation from BSI.

Start/End Date and Time Location Fee Enroll
  • Aug 26, 2019 8:00 AM - 5:30 PM
  • Aug 27, 2019 8:00 AM - 6:30 PM
Princeton, NJ
Hyatt Place Princeton
3565 US Highway 1
Princeton, NJ 08540
United States
(609) 720.0200
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USD $1295.00Enroll
  • Sep 16, 2019 8:00 AM - 5:30 PM
  • Sep 17, 2019 8:00 AM - 6:30 PM
San Diego, CA
Country Inn and Suites by Carlson-San Diego North
5975 Lusk Boulevard
San Diego, CA 92121
United States
858/558-1818
View Location Websitemap this location
USD $1295.00Enroll
  • Sep 23, 2019 8:00 AM - 5:30 PM
  • Sep 24, 2019 8:00 AM - 6:30 PM
Dallas, TXUSD $1295.00Enroll
  • Sep 30, 2019 8:00 AM - 5:30 PM
  • Oct 01, 2019 8:00 AM - 6:30 PM
Atlanta, GAUSD $1295.00Enroll
  • Oct 07, 2019 8:00 AM - 5:30 PM
  • Oct 08, 2019 8:00 AM - 6:30 PM
Chicago, IL
Hyatt Place Chicago Midway
6550 Cicero Avenue
Bedford Park, IL 60638
United States
(708) 594-1400map this location
USD $1295.00Enroll
  • Oct 07, 2019 8:00 AM - 5:30 PM
  • Oct 08, 2019 8:00 AM - 6:30 PM
Princeton, NJUSD $1295.00Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
Orlando, FLUSD $1295.00Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
Seattle, WAUSD $1295.00Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
San José, CAUSD $1295.00Enroll
  • Nov 04, 2019 8:00 AM - 5:30 PM
  • Nov 05, 2019 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Nov 04, 2019 8:00 AM - 5:30 PM
  • Nov 05, 2019 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Nov 18, 2019 8:00 AM - 5:30 PM
  • Nov 19, 2019 8:00 AM - 6:30 PM
Boston, MA
Courtyard Boston Logan Airport
225 William McClellan Highway
Boston, MA 02128
United States
(617) 933-1111map this location
USD $1195.00*Enroll
  • Dec 02, 2019 8:00 AM - 5:30 PM
  • Dec 03, 2019 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Dec 02, 2019 8:00 AM - 5:30 PM
  • Dec 03, 2019 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Dec 09, 2019 8:00 AM - 5:30 PM
  • Dec 10, 2019 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Dec 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 2019 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Dec 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 2019 8:00 AM - 6:30 PM
Dulles, VAUSD $1195.00*Enroll