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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.

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.

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
  • Apr 01, 2019 8:00 AM - 5:30 PM
  • Apr 02, 2019 8:00 AM - 6:30 PM
Orlando, FL
Crowne Plaza Orlando Universal
7800 Universal Blvd
Orlando, FL 32819
United States
407-355-0550map this location
USD $1295.00Enroll
  • Apr 08, 2019 8:00 AM - 5:30 PM
  • Apr 09, 2019 8:00 AM - 6:30 PM
Seattle, WA
Crowne Plaza Seattle Airport
17338 International Boulevard
Seattle, WA 98188
United States
(206) 428-2123map this location
USD $1295.00Enroll
  • Apr 08, 2019 8:00 AM - 5:30 PM
  • Apr 09, 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 $1295.00Enroll
  • Apr 23, 2019 8:00 AM - 5:30 PM
  • Apr 24, 2019 8:00 AM - 6:30 PM
Atlanta, GAUSD $1295.00Enroll
  • Apr 29, 2019 8:00 AM - 5:30 PM
  • Apr 30, 2019 8:00 AM - 6:30 PM
Dallas, TX
DoubleTree Dallas - Campbell Centre
8250 N. Central Expressway
Dallas, TX 75206-1888
United States
2146918700
View Location Websitemap this location
USD $1295.00Enroll
  • May 06, 2019 8:00 AM - 5:30 PM
  • May 07, 2019 8:00 AM - 6:30 PM
San José, CA
Biltmore Hotel and Suites
2151 Laurelwood Road
Santa Clara, CA 95054
United States
408/988-8411
View Location Websitemap this location
USD $1295.00Enroll
  • May 13, 2019 8:00 AM - 5:30 PM
  • May 14, 2019 8:00 AM - 6:30 PM
Princeton, NJUSD $1295.00Enroll
  • May 13, 2019 8:00 AM - 5:30 PM
  • May 14, 2019 8:00 AM - 6:30 PM
Boston, MAUSD $1295.00Enroll
  • May 28, 2019 8:00 AM - 5:30 PM
  • May 29, 2019 8:00 AM - 6:30 PM
Minneapolis, MN
Hyatt Place Minneapolis Downtown
425 7th Street South
Minneapolis, MN 55415
United States
(912) 333 3111
View Location Websitemap this location
USD $1195.00*Enroll
  • Jun 03, 2019 8:00 AM - 5:30 PM
  • Jun 04, 2019 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Jun 10, 2019 8:00 AM - 5:30 PM
  • Jun 11, 2019 8:00 AM - 6:30 PM
Dallas, TXUSD $1195.00*Enroll
  • Jun 10, 2019 8:00 AM - 5:30 PM
  • Jun 11, 2019 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Jun 17, 2019 8:00 AM - 5:30 PM
  • Jun 18, 2019 8:00 AM - 6:30 PM
Orlando, FLUSD $1195.00*Enroll
  • Jun 24, 2019 8:00 AM - 5:30 PM
  • Jun 25, 2019 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • Jul 08, 2019 8:00 AM - 5:30 PM
  • Jul 09, 2019 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Jul 15, 2019 8:00 AM - 5:30 PM
  • Jul 16, 2019 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Jul 22, 2019 8:00 AM - 5:30 PM
  • Jul 23, 2019 8:00 AM - 6:30 PM
Dulles, VAUSD $1195.00*Enroll
  • Jul 29, 2019 8:00 AM - 5:30 PM
  • Jul 30, 2019 8:00 AM - 6:30 PM
Seattle, WAUSD $1195.00*Enroll
  • Aug 05, 2019 8:00 AM - 5:30 PM
  • Aug 06, 2019 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Aug 19, 2019 8:00 AM - 5:30 PM
  • Aug 20, 2019 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Aug 19, 2019 8:00 AM - 5:30 PM
  • Aug 20, 2019 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Aug 26, 2019 8:00 AM - 5:30 PM
  • Aug 27, 2019 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Sep 16, 2019 8:00 AM - 5:30 PM
  • Sep 17, 2019 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Sep 23, 2019 8:00 AM - 5:30 PM
  • Sep 24, 2019 8:00 AM - 6:30 PM
Dallas, TXUSD $1195.00*Enroll
  • Sep 30, 2019 8:00 AM - 5:30 PM
  • Oct 01, 2019 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Oct 07, 2019 8:00 AM - 5:30 PM
  • Oct 08, 2019 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
Orlando, FLUSD $1195.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
Seattle, WAUSD $1195.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • 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 18, 2019 8:00 AM - 5:30 PM
  • Nov 19, 2019 8:00 AM - 6:30 PM
Boston, MAUSD $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 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 2019 8:00 AM - 6:30 PM
Dulles, VAUSD $1195.00*Enroll