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Course Details

ISO 13485:2016 Requirements (TPECS)

Course Area

Medical Devices

Continuing Education Units

1.6

Course Fee

USD $1295.00

Early Bird Price*

USD $1195.00

Upcoming Sessions
Oct 18-19, 2021 - Live Online - Full DayEnroll
Oct 25-28, 2021 - Live Online - Half DayEnroll
Oct 25-26, 2021 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

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
Oct 18, 2021 11:00 AM - 8:30 PM ET
Oct 19, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Oct 25, 2021 8:30 AM - 1:00 PM ET
Oct 26, 2021 8:30 AM - 1:00 PM ET
Oct 27, 2021 8:30 AM - 1:00 PM ET
Oct 28, 2021 8:30 AM - 1:00 PM ET
Live Online - Half DayUSD $1295.00Enroll
Oct 25, 2021 9:00 AM - 5:30 PM ET
Oct 26, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Nov 1, 2021 9:00 AM - 5:30 PM ET
Nov 2, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Nov 8, 2021 9:00 AM - 5:30 PM ET
Nov 9, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Nov 8, 2021 2:00 PM - 6:30 PM ET
Nov 9, 2021 2:00 PM - 6:30 PM ET
Nov 10, 2021 2:00 PM - 6:30 PM ET
Nov 11, 2021 2:00 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Nov 15, 2021 11:00 AM - 8:30 PM ET
Nov 16, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Nov 29, 2021 9:00 AM - 5:30 PM ET
Nov 30, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Nov 29, 2021 2:00 PM - 6:30 PM ET
Nov 30, 2021 2:00 PM - 6:30 PM ET
Dec 1, 2021 2:00 PM - 6:30 PM ET
Dec 2, 2021 2:00 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Dec 6, 2021 9:00 AM - 5:30 PM ET
Dec 7, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Dec 13, 2021 8:00 AM - 5:30 PM
Dec 14, 2021 8:00 AM - 6:30 PM
Nashville, TNUSD $1295.00Enroll
Dec 13, 2021 8:30 AM - 1:00 PM ET
Dec 14, 2021 8:30 AM - 1:00 PM ET
Dec 15, 2021 8:30 AM - 1:00 PM ET
Dec 16, 2021 8:30 AM - 1:00 PM ET
Live Online - Half DayUSD $1295.00Enroll
Dec 13, 2021 9:00 AM - 5:30 PM ET
Dec 14, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Dec 20, 2021 11:00 AM - 8:30 PM ET
Dec 21, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jan 3, 2022 11:00 AM - 8:30 PM ET
Jan 4, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jan 10, 2022 8:00 AM - 5:30 PM
Jan 11, 2022 8:00 AM - 6:30 PM
Dulles, VAUSD $1295.00Enroll
Jan 10, 2022 9:00 AM - 5:30 PM ET
Jan 11, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jan 17, 2022 9:00 AM - 1:00 PM ET
Jan 18, 2022 9:00 AM - 1:00 PM ET
Jan 19, 2022 9:00 AM - 1:00 PM ET
Jan 20, 2022 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1295.00Enroll
Jan 17, 2022 11:00 AM - 8:30 PM ET
Jan 18, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jan 24, 2022 9:00 AM - 5:30 PM ET
Jan 25, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jan 31, 2022 8:00 AM - 5:30 PM
Feb 1, 2022 8:00 AM - 6:30 PM
Orlando, FLUSD $1295.00Enroll
Jan 31, 2022 9:00 AM - 5:30 PM ET
Feb 1, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 7, 2022 11:00 AM - 8:30 PM ET
Feb 8, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 14, 2022 9:00 AM - 5:30 PM ET
Feb 15, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 14, 2022 2:30 PM - 6:30 PM ET
Feb 15, 2022 2:30 PM - 6:30 PM ET
Feb 16, 2022 2:30 PM - 6:30 PM ET
Feb 17, 2022 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Feb 21, 2022 9:00 AM - 5:30 PM ET
Feb 22, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 28, 2022 8:00 AM - 5:30 PM
Mar 1, 2022 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1295.00Enroll
Feb 28, 2022 9:00 AM - 5:30 PM ET
Mar 1, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 7, 2022 9:00 AM - 1:00 PM ET
Mar 8, 2022 9:00 AM - 1:00 PM ET
Mar 9, 2022 9:00 AM - 1:00 PM ET
Mar 10, 2022 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1295.00Enroll
Mar 7, 2022 11:00 AM - 8:30 PM ET
Mar 8, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 14, 2022 9:00 AM - 5:30 PM ET
Mar 15, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 21, 2022 8:00 AM - 5:30 PM
Mar 22, 2022 8:00 AM - 6:30 PM
San José, CAUSD $1295.00Enroll
Mar 21, 2022 9:00 AM - 5:30 PM ET
Mar 22, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 28, 2022 11:00 AM - 8:30 PM ET
Mar 29, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 4, 2022 9:00 AM - 5:30 PM ET
Apr 5, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 4, 2022 2:30 PM - 6:30 PM ET
Apr 5, 2022 2:30 PM - 6:30 PM ET
Apr 6, 2022 2:30 PM - 6:30 PM ET
Apr 7, 2022 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Apr 11, 2022 9:00 AM - 5:30 PM ET
Apr 12, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 18, 2022 8:00 AM - 5:30 PM
Apr 19, 2022 8:00 AM - 6:30 PM
Nashville, TNUSD $1295.00Enroll
Apr 18, 2022 9:00 AM - 5:30 PM ET
Apr 19, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 25, 2022 11:00 AM - 8:30 PM ET
Apr 26, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 2, 2022 11:00 AM - 8:30 PM ET
May 3, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 9, 2022 9:00 AM - 1:00 PM ET
May 10, 2022 9:00 AM - 1:00 PM ET
May 11, 2022 9:00 AM - 1:00 PM ET
May 12, 2022 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1295.00Enroll
May 9, 2022 9:00 AM - 5:30 PM ET
May 10, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 16, 2022 9:00 AM - 5:30 PM ET
May 17, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 23, 2022 8:00 AM - 5:30 PM
May 24, 2022 8:00 AM - 6:30 PM
Dulles, VAUSD $1295.00Enroll
May 24, 2022 11:00 AM - 8:30 PM ET
May 25, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 31, 2022 11:00 AM - 8:30 PM ET
Jun 1, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jun 6, 2022 2:30 PM - 6:30 PM ET
Jun 7, 2022 2:30 PM - 6:30 PM ET
Jun 8, 2022 2:30 PM - 6:30 PM ET
Jun 9, 2022 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Jun 13, 2022 9:00 AM - 5:30 PM ET
Jun 14, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jun 20, 2022 8:00 AM - 5:30 PM
Jun 21, 2022 8:00 AM - 6:30 PM
San José, CAUSD $1295.00Enroll
Jun 20, 2022 9:00 AM - 5:30 PM ET
Jun 21, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jun 27, 2022 11:00 AM - 8:30 PM ET
Jun 28, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll

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

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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