ISO 13485:2016 Requirements (Live Online)

Course Area

Medical Devices

Continuing Education Units

1.6

Course Fee

USD $1295.00

Early Bird Price*

USD $1195.00

Upcoming Sessions
Jun 28-29, 2021 - Live Online - Full DayEnroll
Jul 12-13, 2021 - Live Online - Full DayEnroll
Jul 12-13, 2021 - Salt Lake City, UTEnroll

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
Jun 28, 2021 9:00 AM - 5:30 PM ET
Jun 29, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Jul 12, 2021 11:00 AM - 8:30 PM ET
Jul 13, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Jul 12, 2021 8:00 AM - 5:30 PM
Jul 13, 2021 8:00 AM - 6:30 PM
Salt Lake City, UT USD $1295.00 Enroll
Jul 12, 2021 2:30 PM - 7:00 PM ET
Jul 13, 2021 2:30 PM - 7:00 PM ET
Jul 14, 2021 2:30 PM - 7:00 PM ET
Jul 15, 2021 2:30 PM - 7:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Jul 19, 2021 9:00 AM - 5:30 PM ET
Jul 20, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Jul 19, 2021 8:00 AM - 4:30 PM
Jul 20, 2021 8:00 AM - 4:30 PM
San José, CA USD $1295.00 Enroll
Jul 26, 2021 11:00 AM - 7:30 PM ET
Jul 27, 2021 11:00 AM - 7:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Jul 26, 2021 2:30 PM - 7:00 PM ET
Jul 27, 2021 2:30 PM - 7:00 PM ET
Jul 28, 2021 2:30 PM - 7:00 PM ET
Jul 29, 2021 2:30 PM - 7:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Aug 2, 2021 9:00 AM - 5:30 PM ET
Aug 3, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Aug 9, 2021 11:00 AM - 8:30 PM ET
Aug 10, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Aug 9, 2021 2:30 PM - 7:00 PM ET
Aug 10, 2021 2:30 PM - 7:00 PM ET
Aug 11, 2021 2:30 PM - 7:00 PM ET
Aug 12, 2021 2:30 PM - 7:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Aug 16, 2021 8:00 AM - 5:30 PM
Aug 17, 2021 8:00 AM - 6:30 PM
Nashville, TN USD $1295.00 Enroll
Aug 16, 2021 9:00 AM - 5:30 PM ET
Aug 17, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Aug 23, 2021 9:00 AM - 5:30 PM ET
Aug 24, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Aug 23, 2021 2:30 PM - 7:00 PM ET
Aug 24, 2021 2:30 PM - 7:00 PM ET
Aug 25, 2021 2:30 PM - 7:00 PM ET
Aug 26, 2021 2:30 PM - 7:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Aug 30, 2021 9:00 AM - 5:30 PM ET
Aug 31, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Sep 7, 2021 11:00 AM - 8:30 PM ET
Sep 8, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Sep 13, 2021 9:00 AM - 5:30 PM ET
Sep 14, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Sep 13, 2021 8:00 AM - 5:30 PM
Sep 14, 2021 8:00 AM - 6:30 PM
Dulles, VA USD $1295.00 Enroll
Sep 13, 2021 2:30 PM - 7:00 PM ET
Sep 14, 2021 2:30 PM - 7:00 PM ET
Sep 15, 2021 2:30 PM - 7:00 PM ET
Sep 16, 2021 2:30 PM - 7:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Sep 20, 2021 9:00 AM - 5:30 PM ET
Sep 21, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Sep 27, 2021 11:00 AM - 8:30 PM ET
Sep 28, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Sep 27, 2021 2:30 PM - 7:00 PM ET
Sep 28, 2021 2:30 PM - 7:00 PM ET
Sep 29, 2021 2:30 PM - 7:00 PM ET
Sep 30, 2021 2:30 PM - 7:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Oct 4, 2021 9:00 AM - 5:30 PM ET
Oct 5, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Oct 11, 2021 9:00 AM - 5:30 PM ET
Oct 12, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Oct 11, 2021 2:30 PM - 6:30 PM ET
Oct 12, 2021 2:30 PM - 6:30 PM ET
Oct 13, 2021 2:30 PM - 6:30 PM ET
Oct 14, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1295.00 Enroll
Oct 11, 2021 8:00 AM - 5:30 PM
Oct 12, 2021 8:00 AM - 6:30 PM
Orlando, FL USD $1295.00 Enroll
Oct 18, 2021 11:00 AM - 8:30 PM ET
Oct 19, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Oct 25, 2021 9:00 AM - 5:30 PM ET
Oct 26, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Oct 25, 2021 9:00 AM - 1:00 PM ET
Oct 26, 2021 9:00 AM - 1:00 PM ET
Oct 27, 2021 9:00 AM - 1:00 PM ET
Oct 28, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Nov 1, 2021 8:00 AM - 5:30 PM
Nov 2, 2021 8:00 AM - 6:30 PM
Salt Lake City, UT USD $1295.00 Enroll
Nov 1, 2021 9:00 AM - 5:30 PM ET
Nov 2, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Nov 8, 2021 9:00 AM - 5:30 PM ET
Nov 9, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Nov 8, 2021 9:00 AM - 1:00 PM ET
Nov 9, 2021 9:00 AM - 1:00 PM ET
Nov 10, 2021 9:00 AM - 1:00 PM ET
Nov 11, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Nov 15, 2021 11:00 AM - 8:30 PM ET
Nov 16, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Nov 29, 2021 9:00 AM - 5:30 PM ET
Nov 30, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Nov 29, 2021 2:30 PM - 6:30 PM ET
Nov 30, 2021 2:30 PM - 6:30 PM ET
Dec 1, 2021 2:30 PM - 6:30 PM ET
Dec 2, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1295.00 Enroll
Dec 6, 2021 9:00 AM - 5:30 PM ET
Dec 7, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Dec 13, 2021 9:00 AM - 5:30 PM ET
Dec 14, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1295.00 Enroll
Dec 13, 2021 9:00 AM - 1:00 PM ET
Dec 14, 2021 9:00 AM - 1:00 PM ET
Dec 15, 2021 9:00 AM - 1:00 PM ET
Dec 16, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1295.00 Enroll
Dec 13, 2021 8:00 AM - 5:30 PM
Dec 14, 2021 8:00 AM - 6:30 PM
Nashville, TN USD $1295.00 Enroll
Dec 20, 2021 11:00 AM - 8:30 PM ET
Dec 21, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1295.00 Enroll

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

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.