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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

Start/End Date and Time Location Fee Enroll
  • Mar 05, 2018 8:00 AM - 5:30 PM
  • Mar 06, 2018 8:00 AM - 6:30 PM
Princeton, NJ
Courtyard by Marriott Princeton
3815 U.S. Highway 1
@ Mapleton Princeton
Princeton, NJ 08540
United States
(609)436-8964
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USD $1295.00Enroll
  • Mar 12, 2018 8:00 AM - 5:30 PM
  • Mar 13, 2018 8:00 AM - 6:30 PM
Seattle, WA
Hilton Seattle Airport & Conference Center
17620 International Boulevard
Seattle, WA 98188
United States
(206) 901-5910
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USD $1295.00Enroll
  • Mar 12, 2018 8:00 AM - 5:30 PM
  • Mar 13, 2018 8:00 AM - 6:30 PM
Boston, MA
Embassy Suites by Hilton Boston Waltham
550 Winter Street
Waltham, MA 02451
United States
1-781-890-6767
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USD $1295.00Enroll
  • Mar 19, 2018 8:00 AM - 5:30 PM
  • Mar 20, 2018 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
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USD $1295.00Enroll
  • Mar 19, 2018 8:00 AM - 5:30 PM
  • Mar 20, 2018 8:00 AM - 6:30 PM
Atlanta, GA
Holiday Inn Express-Buckhead
800 Sidney Marcus Boulevard
Atlanta, GA 30324
United States
(404) 949-4000
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USD $1295.00Enroll
  • Mar 19, 2018 8:00 AM - 5:30 PM
  • Mar 20, 2018 8:00 AM - 6:30 PM
Memphis, TNUSD $1295.00Enroll
  • Mar 26, 2018 8:00 AM - 5:30 PM
  • Mar 27, 2018 8:00 AM - 6:30 PM
Minneapolis, MN
DoubleTree by Hilton-Minneapolis North
2200 Freeway Boulevard
Minneapolis, MN 55430
United States
(763) 566-8000
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USD $1295.00Enroll
  • Apr 02, 2018 8:00 AM - 5:30 PM
  • Apr 03, 2018 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1295.00Enroll
  • Apr 16, 2018 8:00 AM - 5:30 PM
  • Apr 17, 2018 8:00 AM - 6:30 PM
San Diego, CAUSD $1295.00Enroll
  • May 01, 2018 8:00 AM - 5:30 PM
  • May 02, 2018 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • May 01, 2018 8:00 AM - 5:30 PM
  • May 02, 2018 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • May 07, 2018 8:00 AM - 5:30 PM
  • May 08, 2018 8:00 AM - 6:30 PM
Raleigh, NCUSD $1195.00*Enroll
  • May 14, 2018 8:00 AM - 5:30 PM
  • May 15, 2018 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • May 21, 2018 8:00 AM - 5:30 PM
  • May 22, 2018 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Jun 04, 2018 8:00 AM - 5:30 PM
  • Jun 05, 2018 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Jun 11, 2018 8:00 AM - 5:30 PM
  • Jun 12, 2018 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Jun 11, 2018 8:00 AM - 5:30 PM
  • Jun 12, 2018 8:00 AM - 6:30 PM
Seattle, WAUSD $1195.00*Enroll
  • Jun 11, 2018 8:00 AM - 5:30 PM
  • Jun 12, 2018 8:00 AM - 6:30 PM
Memphis, TNUSD $1195.00*Enroll
  • Jun 19, 2018 8:00 AM - 5:30 PM
  • Jun 20, 2018 8:00 AM - 6:30 PM
Orlando, FLUSD $1195.00*Enroll
  • Jun 25, 2018 8:00 AM - 5:30 PM
  • Jun 26, 2018 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll