Course Details

ISO 13485:2016 Requirements (TPECS)

Course Area

Medical Devices

Course Duration

2 Days

Continuing Education Units

1.6

Course Fee

CAD $1375.00

Early Bird Price*

CAD $1275.00

Upcoming Sessions
Jun 17-18, 2024 - Live Online - Full DayEnroll
Jun 24-25, 2024 - Live Online - Full DayEnroll
Jul 2-3, 2024 - Live Online - Full DayEnroll

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
Jun 17, 2024 9:00 AM - 5:30 PM ET
Jun 18, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Jun 24, 2024 11:00 AM - 8:30 PM ET
Jun 25, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Jul 2, 2024 9:00 AM - 5:30 PM ET
Jul 3, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Jul 8, 2024 9:00 AM - 5:30 PM ET
Jul 9, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Jul 15, 2024 8:30 AM - 5:00 PM
Jul 16, 2024 8:30 AM - 5:00 PM
Hamilton, ON
TOWNEPLACE SUITES BY MARRIOTT®
CAD $1375.00Enroll
Jul 15, 2024 11:00 AM - 7:30 PM ET
Jul 16, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Jul 22, 2024 9:00 AM - 5:30 PM ET
Jul 23, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Jul 29, 2024 9:00 AM - 5:30 PM ET
Jul 30, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Aug 6, 2024 11:00 AM - 7:30 PM ET
Aug 7, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Aug 12, 2024 9:00 AM - 5:30 PM ET
Aug 13, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Aug 26, 2024 9:00 AM - 5:30 PM ET
Aug 27, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Sep 3, 2024 11:00 AM - 8:30 PM ET
Sep 4, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Sep 9, 2024 9:00 AM - 5:30 PM ET
Sep 10, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Sep 16, 2024 2:30 PM - 6:30 PM ET
Sep 17, 2024 2:30 PM - 6:30 PM ET
Sep 18, 2024 2:30 PM - 6:30 PM ET
Sep 19, 2024 2:30 PM - 6:30 PM ET
Live Online - Half DayCAD $1375.00Enroll
Sep 23, 2024 8:30 AM - 5:00 PM
Sep 24, 2024 8:30 AM - 5:00 PM
Laval, QC
Le St-Martin Hôtel & Suites Laval ,1400, rue Maurice-Gauvin Laval, Québec H7S 2P1
CAD $1375.00Enroll
Sep 23, 2024 11:00 AM - 8:30 PM ET
Sep 24, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Sep 30, 2024 9:00 AM - 5:30 PM ET
Oct 1, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Oct 7, 2024 8:30 AM - 5:00 PM
Oct 8, 2024 8:30 AM - 5:00 PM
Mississauga, ON
DoubleTree by Hilton Hotel Toronto Airport West
5444 Dixie Road
Mississauga, ON L4W 2L2
Canada
905-206-5911
View Location Website
map location
CAD $1375.00Enroll
Oct 7, 2024 9:00 AM - 5:30 PM ET
Oct 8, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Oct 15, 2024 11:00 AM - 7:30 PM ET
Oct 16, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Oct 22, 2024 9:00 AM - 5:30 PM ET
Oct 23, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Oct 28, 2024 9:00 AM - 5:30 PM ET
Oct 29, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Nov 4, 2024 11:00 AM - 8:30 PM ET
Nov 5, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Nov 11, 2024 9:00 AM - 1:00 PM ET
Nov 12, 2024 9:00 AM - 1:00 PM ET
Nov 13, 2024 9:00 AM - 1:00 PM ET
Nov 14, 2024 9:00 AM - 1:00 PM ET
Live Online - Half DayCAD $1375.00Enroll
Nov 25, 2024 8:30 AM - 5:00 PM
Nov 26, 2024 8:30 AM - 5:00 PM
Hamilton, ON
TOWNEPLACE SUITES BY MARRIOTT®
CAD $1375.00Enroll
Nov 25, 2024 9:00 AM - 5:30 PM ET
Nov 26, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Dec 3, 2024 11:00 AM - 8:30 PM ET
Dec 4, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Dec 9, 2024 9:00 AM - 5:30 PM ET
Dec 10, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Dec 16, 2024 9:00 AM - 5:30 PM ET
Dec 17, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll
Dec 23, 2024 9:00 AM - 5:30 PM ET
Dec 24, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $1375.00Enroll

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

Recommended Qualification Pathways

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

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Questions?

For questions regarding any of our courses, contact us or call 1.800.862.6752.

Questions?

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

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