ISO 13485:2016 Requirements

Description

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. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class “Essentials of ISO 13485:2003” prior to attending the classroom training.

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 TimeLocationFeeEnroll
  • Aug 28, 2017 8:00 AM - 5:30 PM
  • Aug 29, 2017 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
  • Aug 28, 2017 8:00 AM - 5:30 PM
  • Aug 29, 2017 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 11, 2017 8:00 AM - 5:30 PM
  • Sep 12, 2017 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
  • Sep 18, 2017 8:00 AM - 5:30 PM
  • Sep 19, 2017 8:00 AM - 6:30 PM
Raleigh, NC
DoubleTree by Hilton Hotel Raleigh - Cary
500 Caitboo Avenue
Cary, NC 27518
United States
919-239-4777
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USD $1295.00Enroll
  • Sep 18, 2017 8:00 AM - 5:30 PM
  • Sep 19, 2017 8:00 AM - 6:30 PM
Portland, ORUSD $1295.00Enroll
  • Sep 25, 2017 8:00 AM - 5:30 PM
  • Sep 26, 2017 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
  • Sep 25, 2017 8:00 AM - 5:30 PM
  • Sep 26, 2017 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
  • Oct 10, 2017 8:00 AM - 5:30 PM
  • Oct 11, 2017 8:00 AM - 6:30 PM
Chicago, IL
Residence Inn Chicago Schaumburg
1610 McConnor Parkway
Schaumburg, IL 60173
United States
847.517.9200
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USD $1295.00Enroll
  • Oct 16, 2017 8:00 AM - 5:30 PM
  • Oct 17, 2017 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
  • Oct 23, 2017 8:00 AM - 5:30 PM
  • Oct 24, 2017 8:00 AM - 6:30 PM
Milwaukee, WIUSD $1195.00*Enroll
  • Nov 06, 2017 8:00 AM - 5:30 PM
  • Nov 07, 2017 8:00 AM - 6:30 PM
Memphis, TNUSD $1195.00*Enroll
  • Nov 13, 2017 8:00 AM - 5:30 PM
  • Nov 14, 2017 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
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USD $1195.00*Enroll
  • Nov 27, 2017 8:00 AM - 5:30 PM
  • Nov 28, 2017 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Nov 27, 2017 8:00 AM - 5:30 PM
  • Nov 28, 2017 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Dec 04, 2017 8:00 AM - 5:30 PM
  • Dec 05, 2017 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll