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

You will have the option to receive your course materials in the following formats:

  • 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 available 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.

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 TimeLocationFeeEnroll
  • Apr 20, 2020 8:00 AM - 5:30 PM
  • Apr 21, 2020 8:00 AM - 6:30 PM
Salt Lake City, UT
Hilton Garden Inn Salt Lake Downtown
250 West 600 South
Salt Lake City, UT 84101
United States
(801) 364-5200map this location
USD $1295.00Enroll
  • Apr 27, 2020 8:00 AM - 5:30 PM
  • Apr 28, 2020 8:00 AM - 6:30 PM
Dallas, TXUSD $1295.00Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1295.00Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1295.00Enroll
  • May 11, 2020 8:00 AM - 5:30 PM
  • May 12, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1295.00Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
Chicago, ILUSD $1295.00Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1295.00Enroll
  • May 19, 2020 8:00 AM - 5:30 PM
  • May 20, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1295.00Enroll
  • 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
  • Jul 06, 2020 8:00 AM - 5:30 PM
  • Jul 07, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Jul 13, 2020 8:00 AM - 5:30 PM
  • Jul 14, 2020 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Jul 13, 2020 8:00 AM - 5:30 PM
  • Jul 14, 2020 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1195.00*Enroll
  • Jul 20, 2020 8:00 AM - 5:30 PM
  • Jul 21, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Jul 27, 2020 8:00 AM - 5:30 PM
  • Jul 28, 2020 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Jul 27, 2020 8:00 AM - 5:30 PM
  • Jul 28, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Aug 03, 2020 8:00 AM - 5:30 PM
  • Aug 04, 2020 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Aug 10, 2020 8:00 AM - 5:30 PM
  • Aug 11, 2020 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • Aug 10, 2020 8:00 AM - 5:30 PM
  • Aug 11, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Aug 17, 2020 8:00 AM - 5:30 PM
  • Aug 18, 2020 8:00 AM - 6:30 PM
Dulles, VAUSD $1195.00*Enroll
  • Aug 24, 2020 8:00 AM - 5:30 PM
  • Aug 25, 2020 8:00 AM - 6:30 PM
Nashville, TNUSD $1195.00*Enroll
  • Aug 24, 2020 8:00 AM - 5:30 PM
  • Aug 25, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Aug 31, 2020 8:00 AM - 5:30 PM
  • Sep 01, 2020 8:00 AM - 6:30 PM
Seattle, WAUSD $1195.00*Enroll
  • Sep 08, 2020 8:00 AM - 5:30 PM
  • Sep 09, 2020 8:00 AM - 6:30 PM
Dallas, TXUSD $1195.00*Enroll
  • Sep 14, 2020 8:00 AM - 5:30 PM
  • Sep 15, 2020 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Sep 14, 2020 8:00 AM - 5:30 PM
  • Sep 15, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Sep 21, 2020 8:00 AM - 5:30 PM
  • Sep 22, 2020 8:00 AM - 6:30 PM
Phoenix, AZUSD $1195.00*Enroll
  • Sep 28, 2020 8:00 AM - 5:30 PM
  • Sep 29, 2020 8:00 AM - 6:30 PM
Nashville, TNUSD $1195.00*Enroll
  • Sep 28, 2020 8:00 AM - 5:30 PM
  • Sep 29, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Oct 05, 2020 8:00 AM - 5:30 PM
  • Oct 06, 2020 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Oct 05, 2020 8:00 AM - 5:30 PM
  • Oct 06, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Oct 12, 2020 8:00 AM - 5:30 PM
  • Oct 13, 2020 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Oct 12, 2020 8:00 AM - 5:30 PM
  • Oct 13, 2020 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1195.00*Enroll
  • Oct 19, 2020 8:00 AM - 5:30 PM
  • Oct 20, 2020 8:00 AM - 6:30 PM
Dulles, VAUSD $1195.00*Enroll
  • Oct 19, 2020 8:00 AM - 5:30 PM
  • Oct 20, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Oct 26, 2020 8:00 AM - 5:30 PM
  • Oct 27, 2020 8:00 AM - 6:30 PM
Denver, COUSD $1195.00*Enroll
  • Nov 02, 2020 8:00 AM - 5:30 PM
  • Nov 03, 2020 8:00 AM - 6:30 PM
Nashville, TNUSD $1195.00*Enroll
  • Nov 02, 2020 8:00 AM - 5:30 PM
  • Nov 03, 2020 8:00 AM - 6:30 PM
Phoenix, AZUSD $1195.00*Enroll
  • Nov 09, 2020 8:00 AM - 5:30 PM
  • Nov 10, 2020 8:00 AM - 6:30 PM
Seattle, WAUSD $1195.00*Enroll
  • Nov 16, 2020 8:00 AM - 5:30 PM
  • Nov 17, 2020 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Nov 30, 2020 8:00 AM - 5:30 PM
  • Dec 01, 2020 8:00 AM - 6:30 PM
Dallas, TXUSD $1195.00*Enroll
  • Nov 30, 2020 8:00 AM - 5:30 PM
  • Dec 01, 2020 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Dec 07, 2020 8:00 AM - 5:30 PM
  • Dec 08, 2020 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Dec 07, 2020 8:00 AM - 5:30 PM
  • Dec 08, 2020 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1195.00*Enroll
  • Dec 14, 2020 8:00 AM - 5:30 PM
  • Dec 15, 2020 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • Dec 14, 2020 8:00 AM - 5:30 PM
  • Dec 15, 2020 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll

Whittington & Associates

We are committed to providing expert training, effective consulting, and valuable auditing. If you have any questions about our services, please contact us at 770-862-1766, or Larry@WhittingtonAssociates.com.