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 4, 2023 9:00 AM - 5:30 PM ET Dec 5, 2023 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Dec 11, 2023 9:00 AM - 5:30 PM ET Dec 12, 2023 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Dec 18, 2023 8:00 AM - 5:30 PM Dec 19, 2023 8:00 AM - 6:30 PM | Orlando, FL Hotel Kinetic Orlando Universal Blvd 7800 Universal Blvd Orlando, FL 32819 United States 407-355-0550 map location | USD $1375.00 | Enroll |
Jan 3, 2024 9:00 AM - 5:30 PM ET Jan 4, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jan 8, 2024 9:00 AM - 5:30 PM ET Jan 9, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jan 15, 2024 11:00 AM - 8:30 PM ET Jan 16, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jan 22, 2024 9:00 AM - 5:30 PM ET Jan 23, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jan 29, 2024 9:00 AM - 5:30 PM ET Jan 30, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Feb 6, 2024 11:00 AM - 8:30 PM ET Feb 7, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Feb 13, 2024 9:00 AM - 5:30 PM ET Feb 14, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Feb 19, 2024 9:00 AM - 1:00 PM ET Feb 20, 2024 9:00 AM - 1:00 PM ET Feb 21, 2024 9:00 AM - 1:00 PM ET Feb 22, 2024 9:00 AM - 1:00 PM ET | Live Online - Half Day | USD $1375.00 | Enroll |
Feb 26, 2024 9:00 AM - 5:30 PM Feb 27, 2024 9:00 AM - 5:30 PM | Irvine, CA | USD $1375.00 | Enroll |
Feb 26, 2024 11:00 AM - 8:30 PM ET Feb 27, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Mar 4, 2024 9:00 AM - 5:30 PM ET Mar 5, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Mar 11, 2024 8:00 AM - 5:30 PM Mar 12, 2024 8:00 AM - 6:30 PM | Minneapolis, MN | USD $1375.00 | Enroll |
Mar 18, 2024 9:00 AM - 5:30 PM ET Mar 19, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Mar 25, 2024 11:00 AM - 8:30 PM ET Mar 26, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Apr 2, 2024 9:00 AM - 5:30 PM ET Apr 3, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Apr 9, 2024 9:00 AM - 5:30 PM ET Apr 10, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Apr 15, 2024 11:00 AM - 8:30 PM ET Apr 16, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Apr 22, 2024 9:00 AM - 5:30 PM ET Apr 23, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Apr 29, 2024 9:00 AM - 5:30 PM ET Apr 30, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
May 6, 2024 11:00 AM - 8:30 PM ET May 7, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
May 13, 2024 9:00 AM - 5:30 PM ET May 14, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
May 21, 2024 9:00 AM - 1:00 PM ET May 22, 2024 9:00 AM - 1:00 PM ET May 23, 2024 9:00 AM - 1:00 PM ET May 24, 2024 9:00 AM - 1:00 PM ET | Live Online - Half Day | USD $1375.00 | Enroll |
May 28, 2024 8:00 AM - 5:30 PM May 29, 2024 8:00 AM - 6:30 PM | San José, CA | USD $1375.00 | Enroll |
Jun 3, 2024 11:00 AM - 8:30 PM ET Jun 4, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jun 11, 2024 9:00 AM - 5:30 PM ET Jun 12, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jun 17, 2024 9:00 AM - 5:30 PM ET Jun 18, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jun 24, 2024 11:00 AM - 8:30 PM ET Jun 25, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jul 2, 2024 9:00 AM - 5:30 PM ET Jul 3, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jul 8, 2024 9:00 AM - 5:30 PM ET Jul 9, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jul 15, 2024 11:00 AM - 8:30 PM ET Jul 16, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jul 22, 2024 9:00 AM - 5:30 PM ET Jul 23, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Jul 29, 2024 9:00 AM - 5:30 PM ET Jul 30, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Aug 6, 2024 11:00 AM - 8:30 PM ET Aug 7, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Aug 13, 2024 9:00 AM - 5:30 PM ET Aug 14, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Aug 19, 2024 8:00 AM - 5:30 PM Aug 20, 2024 8:00 AM - 6:30 PM | Boston, MA | USD $1375.00 | Enroll |
Aug 26, 2024 9:00 AM - 5:30 PM ET Aug 27, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Sep 3, 2024 11:00 AM - 8:30 PM ET Sep 4, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Sep 9, 2024 9:00 AM - 5:30 PM ET Sep 10, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
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 Day | USD $1375.00 | Enroll |
Sep 23, 2024 11:00 AM - 8:30 PM ET Sep 24, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Sep 30, 2024 9:00 AM - 5:30 PM ET Oct 1, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Oct 7, 2024 9:00 AM - 5:30 PM ET Oct 8, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Oct 15, 2024 11:00 AM - 8:30 PM ET Oct 16, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Oct 22, 2024 9:00 AM - 5:30 PM ET Oct 23, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Oct 28, 2024 9:00 AM - 5:30 PM ET Oct 29, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Nov 4, 2024 11:00 AM - 8:30 PM ET Nov 5, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
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 Day | USD $1375.00 | Enroll |
Nov 18, 2024 8:00 AM - 5:30 PM Nov 19, 2024 8:00 AM - 6:30 PM | Orlando, FL | USD $1375.00 | Enroll |
Nov 25, 2024 9:00 AM - 5:30 PM ET Nov 26, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Dec 3, 2024 11:00 AM - 8:30 PM ET Dec 4, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
Dec 9, 2024 9:00 AM - 5:30 PM ET Dec 10, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | 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 $1375.00 | Enroll |
Dec 23, 2024 9:00 AM - 5:30 PM ET Dec 24, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $1375.00 | Enroll |
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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