Course Area
Course Duration
2 Days
Continuing Education Units
1.6
Course Fee
USD $1170.00
Early Bird Price*
USD $1070.00
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 Day | USD $1170.00 | Enroll |
Jan 2, 2025 9:00 AM - 5:30 PM ET Jan 3, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jan 6, 2025 11:00 AM - 7:30 PM ET Jan 7, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jan 13, 2025 9:00 AM - 5:30 PM ET Jan 14, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jan 20, 2025 9:00 AM - 5:30 PM ET Jan 21, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jan 27, 2025 11:00 AM - 7:30 PM ET Jan 28, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Feb 3, 2025 9:00 AM - 5:30 PM ET Feb 4, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
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 Day | USD $1170.00 | Enroll |
Feb 17, 2025 9:00 AM - 5:30 PM ET Feb 18, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Feb 24, 2025 9:00 AM - 5:30 PM ET Feb 25, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Mar 3, 2025 8:00 AM - 5:30 PM Mar 4, 2025 8:00 AM - 5:30 PM | Minneapolis, MN | USD $1170.00 | Enroll |
Mar 10, 2025 9:00 AM - 5:30 PM ET Mar 11, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Mar 17, 2025 11:00 AM - 7:30 PM ET Mar 18, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Mar 24, 2025 9:00 AM - 5:30 PM ET Mar 25, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Mar 31, 2025 9:00 AM - 5:30 PM ET Apr 1, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Apr 7, 2025 11:00 AM - 7:30 PM ET Apr 8, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Apr 14, 2025 9:00 AM - 5:30 PM ET Apr 15, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Apr 21, 2025 9:00 AM - 5:30 PM ET Apr 22, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Apr 28, 2025 11:00 AM - 7:30 PM ET Apr 29, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
May 5, 2025 9:00 AM - 5:30 PM ET May 6, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
May 12, 2025 9:00 AM - 5:30 PM ET May 13, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
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 Day | USD $1170.00 | Enroll |
May 27, 2025 8:00 AM - 5:30 PM May 28, 2025 8:00 AM - 5:30 PM | San José, CA | USD $1170.00 | Enroll |
Jun 2, 2025 9:00 AM - 5:30 PM ET Jun 3, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jun 9, 2025 9:00 AM - 5:30 PM ET Jun 10, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jun 16, 2025 11:00 AM - 7:30 PM ET Jun 17, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jun 23, 2025 9:00 AM - 5:30 PM ET Jun 24, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jul 2, 2025 11:00 AM - 7:30 PM ET Jul 3, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jul 7, 2025 9:00 AM - 5:30 PM ET Jul 8, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jul 14, 2025 9:00 AM - 5:30 PM ET Jul 15, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jul 21, 2025 11:00 AM - 7:30 PM ET Jul 22, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Jul 28, 2025 9:00 AM - 5:30 PM ET Jul 29, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Aug 5, 2025 8:00 AM - 5:30 PM Aug 6, 2025 8:00 AM - 5:30 PM | Boston, MA | USD $1170.00 | Enroll |
Aug 11, 2025 9:00 AM - 5:30 PM ET Aug 12, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
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 Day | USD $1170.00 | Enroll |
Aug 25, 2025 9:00 AM - 5:30 PM ET Aug 26, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Sep 2, 2025 9:00 AM - 5:30 PM ET Sep 3, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Sep 8, 2025 11:00 AM - 7:30 PM ET Sep 9, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Sep 15, 2025 9:00 AM - 5:30 PM ET Sep 16, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Sep 22, 2025 9:00 AM - 5:30 PM ET Sep 23, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Sep 29, 2025 11:00 AM - 7:30 PM ET Sep 30, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Oct 6, 2025 9:00 AM - 5:30 PM ET Oct 7, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Oct 14, 2025 9:00 AM - 5:30 PM ET Oct 15, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Oct 20, 2025 11:00 AM - 7:30 PM ET Oct 21, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Oct 27, 2025 9:00 AM - 5:30 PM ET Oct 28, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Nov 3, 2025 8:00 AM - 5:30 PM Nov 4, 2025 8:00 AM - 5:30 PM | Irvine, California | USD $1170.00 | Enroll |
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 Day | USD $1170.00 | Enroll |
Nov 10, 2025 11:00 AM - 7:30 PM ET Nov 11, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Nov 24, 2025 9:00 AM - 5:30 PM ET Nov 25, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Dec 1, 2025 9:00 AM - 5:30 PM ET Dec 2, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Dec 8, 2025 9:00 AM - 5:30 PM ET Dec 9, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Dec 15, 2025 11:00 AM - 7:30 PM ET Dec 16, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
Dec 22, 2025 9:00 AM - 5:30 PM ET Dec 23, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1170.00 | Enroll |
The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.