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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.

Hard Copies: At the start of the course, a physical copy of the Student Handbook will be provided.

Soft Copies: Prior to the course, an email with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed, will be sent to students.

NOTE: Copies of the standards are not included in the class fee. BSI will make reasonable efforts to have loaner copies for use during the class, but students are encouraged to bring their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

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
  • Dec 09, 2019 8:00 AM - 5:30 PM
  • Dec 10, 2019 8:00 AM - 6:30 PM
Princeton, NJ
DoubleTree by Hilton - Princeton
4355 Route 1
Princeton, NJ 08540
United States
609-452-2400
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USD $1295.00Enroll
  • Dec 09, 2019 8:00 AM - 5:30 PM
  • Dec 10, 2019 8:00 AM - 6:30 PM
Boston, MA
Courtyard Boston Downtown
275 Tremont Street
Boston, MA 02116
United States
(617) 426-1400
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USD $1295.00Enroll
  • Dec 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 2019 8:00 AM - 6:30 PM
Dulles, VA
Monument II - Chesapeake Boardroom
12950 Worldgate Drive
Herndon, VA 20170
United States
(703) 347-9000map this location
USD $1295.00Enroll
  • Dec 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 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
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USD $1295.00Enroll
  • Jan 06, 2020 8:00 AM - 5:30 PM
  • Jan 07, 2020 8:00 AM - 6:30 PM
Boston, MAUSD $1295.00Enroll
  • Jan 06, 2020 8:00 AM - 5:30 PM
  • Jan 07, 2020 8:00 AM - 6:30 PM
San Diego, CA
Courtyard Marriott San Diego Old Town
2435 Jefferson Street
San Diego, CA 92110
United States
(619) 260-8500map this location
USD $1295.00Enroll
  • Jan 13, 2020 8:00 AM - 5:30 PM
  • Jan 14, 2020 8:00 AM - 6:30 PM
Atlanta, GAUSD $1295.00Enroll
  • Jan 13, 2020 8:00 AM - 5:30 PM
  • Jan 14, 2020 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1295.00Enroll
  • Jan 21, 2020 8:00 AM - 5:30 PM
  • Jan 22, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1295.00Enroll
  • Jan 21, 2020 8:00 AM - 5:30 PM
  • Jan 22, 2020 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 $1295.00Enroll
  • Jan 27, 2020 8:00 AM - 5:30 PM
  • Jan 28, 2020 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
  • Feb 03, 2020 8:00 AM - 5:30 PM
  • Feb 04, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1295.00Enroll
  • Feb 03, 2020 8:00 AM - 5:30 PM
  • Feb 04, 2020 8:00 AM - 6:30 PM
Dallas, TXUSD $1295.00Enroll
  • Feb 10, 2020 8:00 AM - 5:30 PM
  • Feb 11, 2020 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Feb 10, 2020 8:00 AM - 5:30 PM
  • Feb 11, 2020 8:00 AM - 6:30 PM
Phoenix, AZUSD $1195.00*Enroll
  • Feb 18, 2020 8:00 AM - 5:30 PM
  • Feb 19, 2020 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Feb 24, 2020 8:00 AM - 5:30 PM
  • Feb 25, 2020 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Feb 24, 2020 8:00 AM - 5:30 PM
  • Feb 25, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Mar 02, 2020 8:00 AM - 5:30 PM
  • Mar 03, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Mar 09, 2020 8:00 AM - 5:30 PM
  • Mar 10, 2020 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • Mar 09, 2020 8:00 AM - 5:30 PM
  • Mar 10, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Mar 16, 2020 8:00 AM - 5:30 PM
  • Mar 17, 2020 8:00 AM - 6:30 PM
Dulles, VAUSD $1195.00*Enroll
  • Mar 23, 2020 8:00 AM - 5:30 PM
  • Mar 24, 2020 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Mar 23, 2020 8:00 AM - 5:30 PM
  • Mar 24, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Mar 30, 2020 8:00 AM - 5:30 PM
  • Mar 31, 2020 8:00 AM - 6:30 PM
Seattle, WAUSD $1195.00*Enroll
  • Apr 06, 2020 8:00 AM - 5:30 PM
  • Apr 07, 2020 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Apr 14, 2020 8:00 AM - 5:30 PM
  • Apr 15, 2020 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Apr 14, 2020 8:00 AM - 5:30 PM
  • Apr 15, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Apr 20, 2020 8:00 AM - 5:30 PM
  • Apr 21, 2020 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1195.00*Enroll
  • Apr 27, 2020 8:00 AM - 5:30 PM
  • Apr 28, 2020 8:00 AM - 6:30 PM
Dallas, TXUSD $1195.00*Enroll
  • Apr 27, 2020 8:00 AM - 5:30 PM
  • Apr 28, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • May 11, 2020 8:00 AM - 5:30 PM
  • May 12, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • May 19, 2020 8:00 AM - 5:30 PM
  • May 20, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Jun 01, 2020 8:00 AM - 5:30 PM
  • Jun 02, 2020 8:00 AM - 6:30 PM
Dulles, VAUSD $1195.00*Enroll
  • Jun 01, 2020 8:00 AM - 5:30 PM
  • Jun 02, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Jun 08, 2020 8:00 AM - 5:30 PM
  • Jun 09, 2020 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Jun 08, 2020 8:00 AM - 5:30 PM
  • Jun 09, 2020 8:00 AM - 6:30 PM
Seattle, WAUSD $1195.00*Enroll
  • Jun 15, 2020 8:00 AM - 5:30 PM
  • Jun 16, 2020 8:00 AM - 6:30 PM
Phoenix, AZUSD $1195.00*Enroll
  • Jun 22, 2020 8:00 AM - 5:30 PM
  • Jun 23, 2020 8:00 AM - 6:30 PM
Dallas, TXUSD $1195.00*Enroll
  • Jun 22, 2020 8:00 AM - 5:30 PM
  • Jun 23, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Jun 29, 2020 8:00 AM - 5:30 PM
  • Jun 30, 2020 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll