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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
Aug 15-16, 2022 - Live Online - Full DayEnroll
Aug 22-23, 2022 - Nashville, TNEnroll
Aug 29-30, 2022 - 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
Aug 15, 2022 9:00 AM - 5:30 PM ET
Aug 16, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Aug 22, 2022 8:00 AM - 5:30 PM
Aug 23, 2022 8:00 AM - 6:30 PM
Nashville, TN
Aloft Nashville West End
1719 West End Avenue
Nashville, TN 37203
United States
(615) 329-4200 map location
USD $1295.00Enroll
Aug 29, 2022 11:00 AM - 8:30 PM ET
Aug 30, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Sep 6, 2022 8:00 AM - 5:30 PM
Sep 7, 2022 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1295.00Enroll
Sep 12, 2022 9:00 AM - 5:30 PM ET
Sep 13, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Sep 19, 2022 8:00 AM - 5:30 PM
Sep 20, 2022 8:00 AM - 6:30 PM
Princeton, NJUSD $1295.00Enroll
Sep 19, 2022 9:00 AM - 1:00 PM ET
Sep 20, 2022 9:00 AM - 1:00 PM ET
Sep 21, 2022 9:00 AM - 1:00 PM ET
Sep 22, 2022 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1295.00Enroll
Sep 26, 2022 11:00 AM - 8:30 PM ET
Sep 27, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Oct 3, 2022 8:00 AM - 5:30 PM
Oct 4, 2022 8:00 AM - 6:30 PM
San José, CAUSD $1295.00Enroll
Oct 11, 2022 9:00 AM - 5:30 PM ET
Oct 12, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Oct 17, 2022 8:00 AM - 5:30 PM
Oct 18, 2022 8:00 AM - 6:30 PM
Orlando, FLUSD $1295.00Enroll
Oct 24, 2022 11:00 AM - 8:30 PM ET
Oct 25, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Oct 31, 2022 8:00 AM - 5:30 PM
Nov 1, 2022 8:00 AM - 6:30 PM
Salt Lake City, UTUSD $1295.00Enroll
Nov 7, 2022 9:00 AM - 5:30 PM ET
Nov 8, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Nov 14, 2022 8:00 AM - 5:30 PM
Nov 15, 2022 8:00 AM - 6:30 PM
Memphis, TNUSD $1295.00Enroll
Nov 28, 2022 11:00 AM - 8:30 PM ET
Nov 29, 2022 11:00 AM - 8:30 PM ET
Nov 30, 2022 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Nov 28, 2022 2:30 PM - 6:30 PM ET
Nov 29, 2022 2:30 PM - 6:30 PM ET
Nov 30, 2022 2:30 PM - 6:30 PM ET
Dec 1, 2022 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Dec 5, 2022 8:00 AM - 5:30 PM
Dec 6, 2022 8:00 AM - 6:30 PM
San José, CAUSD $1295.00Enroll
Dec 12, 2022 9:00 AM - 5:30 PM ET
Dec 13, 2022 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Dec 19, 2022 8:00 AM - 5:30 PM
Dec 20, 2022 8:00 AM - 6:30 PM
Orlando, FLUSD $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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