Course Details

ISO 13485:2016 Requirements (TPECS)

Student taking online training

Course Area

Medical Devices

Course Duration

2 Days

Continuing Education Units

1.6

Course Fee

USD $1170.00

Early Bird Price*

USD $1070.00

Upcoming Sessions

Dec 16-17, 2024 - Live Online - Full Day Enroll
Jan 2-3, 2025 - Live Online - Full Day Enroll
Jan 6-7, 2025 - Live Online - Full Day Enroll

View all sessions

* Subject to availability

See also

Course Details

BSI's “ISO 13485:2016 Requirements” competency-based that 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 Competency 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

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.

Course Materials

You will have the option to receive your course materials in either hard copy or soft copy:

  • Hard Copy option: You will receive a physical copy of the Student Handbook in the mail prior to the course.
  • Soft Copy option: You will receive an email prior to the course 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.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

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 have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

  • Students need to connect to the class from any internet accessible location.
  • Webcam and Microphone are REQUIRED.
  • ALL course times shown are US EASTERN TIME.

If your class is In-person :

  • You are encouraged to bring a laptop with you to class.
  • Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

Full Day Classes - (Live Online and In-person) There are 2 eight hour sessions*, one per day. There is an online exam at the end of the competency unit, which is in session 2. Exam range is 145 minutes. Detailed exam instructions will be provided. A Certificate of Attainment at the end of the competency unit will be provided for students who are deemed "Competent". A Certificate of Attendance will be provided to those who do not pass the competency exam, and students will be given the opportunity to retake the test(s).

Half Day Classes - (Live Online) There are 4 four hour sessions*, one per day. There is an online exam at the end of the competency unit, which is in session 4. Exam range is 145 minutes. Detailed exam instructions will be provided. A Certificate of Attainment at the end of the competency unit will be provided for students who are deemed "Competent". A Certificate of Attendance will be provided to those who do not pass the competency exam, and students will be given the opportunity to retake the test(s).

All Upcoming Course Dates

Date and Time Location Fees Enroll
Dec 16, 2024 9:00 AM - 5:30 PM ET
Dec 17, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jan 2, 2025 9:00 AM - 5:30 PM ET
Jan 3, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jan 6, 2025 11:00 AM - 7:30 PM ET
Jan 7, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jan 13, 2025 9:00 AM - 5:30 PM ET
Jan 14, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jan 20, 2025 9:00 AM - 5:30 PM ET
Jan 21, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jan 27, 2025 11:00 AM - 7:30 PM ET
Jan 28, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Feb 3, 2025 9:00 AM - 5:30 PM ET
Feb 4, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Feb 10, 2025 2:00 PM - 6:00 PM ET
Feb 11, 2025 2:00 PM - 6:00 PM ET
Feb 12, 2025 2:00 PM - 6:00 PM ET
Feb 13, 2025 2:00 PM - 6:00 PM ET
Live Online - Half DayUSD $1170.00Enroll
Feb 17, 2025 9:00 AM - 5:30 PM ET
Feb 18, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Feb 24, 2025 9:00 AM - 5:30 PM ET
Feb 25, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Mar 3, 2025 8:00 AM - 5:30 PM
Mar 4, 2025 8:00 AM - 5:30 PM
Minneapolis, MNUSD $1170.00Enroll
Mar 10, 2025 9:00 AM - 5:30 PM ET
Mar 11, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Mar 17, 2025 11:00 AM - 7:30 PM ET
Mar 18, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Mar 24, 2025 9:00 AM - 5:30 PM ET
Mar 25, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Mar 31, 2025 9:00 AM - 5:30 PM ET
Apr 1, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Apr 7, 2025 11:00 AM - 7:30 PM ET
Apr 8, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Apr 14, 2025 9:00 AM - 5:30 PM ET
Apr 15, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Apr 21, 2025 9:00 AM - 5:30 PM ET
Apr 22, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Apr 28, 2025 11:00 AM - 7:30 PM ET
Apr 29, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
May 5, 2025 9:00 AM - 5:30 PM ET
May 6, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
May 12, 2025 9:00 AM - 5:30 PM ET
May 13, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
May 20, 2025 9:00 AM - 1:00 PM ET
May 21, 2025 9:00 AM - 1:00 PM ET
May 22, 2025 9:00 AM - 1:00 PM ET
May 23, 2025 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1170.00Enroll
May 27, 2025 8:00 AM - 5:30 PM
May 28, 2025 8:00 AM - 5:30 PM
San José, CAUSD $1170.00Enroll
Jun 2, 2025 9:00 AM - 5:30 PM ET
Jun 3, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jun 9, 2025 9:00 AM - 5:30 PM ET
Jun 10, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jun 16, 2025 11:00 AM - 7:30 PM ET
Jun 17, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jun 23, 2025 9:00 AM - 5:30 PM ET
Jun 24, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jul 2, 2025 11:00 AM - 7:30 PM ET
Jul 3, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jul 7, 2025 9:00 AM - 5:30 PM ET
Jul 8, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jul 14, 2025 9:00 AM - 5:30 PM ET
Jul 15, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jul 21, 2025 11:00 AM - 7:30 PM ET
Jul 22, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Jul 28, 2025 9:00 AM - 5:30 PM ET
Jul 29, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Aug 5, 2025 8:00 AM - 5:30 PM
Aug 6, 2025 8:00 AM - 5:30 PM
Boston, MAUSD $1170.00Enroll
Aug 11, 2025 9:00 AM - 5:30 PM ET
Aug 12, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Aug 18, 2025 2:00 PM - 6:00 PM ET
Aug 19, 2025 2:00 PM - 6:00 PM ET
Aug 20, 2025 2:00 PM - 6:00 PM ET
Aug 21, 2025 2:00 PM - 6:00 PM ET
Live Online - Half DayUSD $1170.00Enroll
Aug 25, 2025 9:00 AM - 5:30 PM ET
Aug 26, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Sep 2, 2025 9:00 AM - 5:30 PM ET
Sep 3, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Sep 8, 2025 11:00 AM - 7:30 PM ET
Sep 9, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Sep 15, 2025 9:00 AM - 5:30 PM ET
Sep 16, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Sep 22, 2025 9:00 AM - 5:30 PM ET
Sep 23, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Sep 29, 2025 11:00 AM - 7:30 PM ET
Sep 30, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Oct 6, 2025 9:00 AM - 5:30 PM ET
Oct 7, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Oct 14, 2025 9:00 AM - 5:30 PM ET
Oct 15, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Oct 20, 2025 11:00 AM - 7:30 PM ET
Oct 21, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Oct 27, 2025 9:00 AM - 5:30 PM ET
Oct 28, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Nov 3, 2025 8:00 AM - 5:30 PM
Nov 4, 2025 8:00 AM - 5:30 PM
Irvine, CaliforniaUSD $1170.00Enroll
Nov 10, 2025 9:00 AM - 1:00 PM ET
Nov 11, 2025 9:00 AM - 1:00 PM ET
Nov 12, 2025 9:00 AM - 1:00 PM ET
Nov 13, 2025 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1170.00Enroll
Nov 10, 2025 11:00 AM - 7:30 PM ET
Nov 11, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Nov 24, 2025 9:00 AM - 5:30 PM ET
Nov 25, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Dec 1, 2025 9:00 AM - 5:30 PM ET
Dec 2, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Dec 8, 2025 9:00 AM - 5:30 PM ET
Dec 9, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Dec 15, 2025 11:00 AM - 7:30 PM ET
Dec 16, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1170.00Enroll
Dec 22, 2025 9:00 AM - 5:30 PM ET
Dec 23, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1170.00Enroll

The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.

ISO 13485:2016 Requirements (TPECS) puts you on the pathway for the following qualifications.

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