BSI's “ISO 13485:2016 Requirements” competency-based 2-day course
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 Attainment for this Exemplar Global Competency Unit.
Students receive comprehensive course manuals with reference materials.
A prior review of the ISO 13485:2016 standard is suggested for this course.
There is a test at the end of Day 2 of this course. Detailed exam instructions will be
provided. A Certificate of Attainment in the MD competency unit will be provided for
students who are deemed “Competent” for the MD competency unit. Certificates
of attendance are provided to those who do not pass the competency test, and students
will be given the opportunity to retake the test.
The venues for scheduled courses are tentative until receipt of course
confirmation from BSI.
Start/End Date and Time |
Location |
Fee |
Enroll |
- Feb 25, 2019 8:00 AM - 5:30 PM
- Feb 26, 2019 8:00 AM - 6:30 PM
| Minneapolis, MN Hyatt Place Minneapolis Downtown 425 7th Street South Minneapolis, MN 55415 United States (912) 333 3111 View Location Websitemap this location | USD $1295.00 | Enroll |
- Mar 18, 2019 8:00 AM - 5:30 PM
- Mar 19, 2019 8:00 AM - 6:30 PM
| Atlanta, GA | USD $1295.00 | Enroll |
- Mar 25, 2019 8:00 AM - 5:30 PM
- Mar 26, 2019 8:00 AM - 6:30 PM
| Chicago, IL | USD $1295.00 | Enroll |
- Mar 25, 2019 8:00 AM - 5:30 PM
- Mar 26, 2019 8:00 AM - 6:30 PM
| San Diego, CA Hilton Garden Inn San Diego Mission Valley/Stadium 3805 Murphy Canyon Road San Diego, CA 92123 United States (858) 278-9300map this location | USD $1295.00 | Enroll |
- Apr 01, 2019 8:00 AM - 5:30 PM
- Apr 02, 2019 8:00 AM - 6:30 PM
| Orlando, FL Crowne Plaza Orlando Universal 7800 Universal Blvd Orlando, FL 32819 United States 407-355-0550map this location | USD $1295.00 | Enroll |
- Apr 08, 2019 8:00 AM - 5:30 PM
- Apr 09, 2019 8:00 AM - 6:30 PM
| Seattle, WA | USD $1295.00 | Enroll |
- Apr 08, 2019 8:00 AM - 5:30 PM
- Apr 09, 2019 8:00 AM - 6:30 PM
| Boston, MA Courtyard Boston Logan Airport 225 William McClellan Highway Boston, MA 02128 United States (617) 933-1111map this location | USD $1295.00 | Enroll |
- Apr 23, 2019 8:00 AM - 5:30 PM
- Apr 24, 2019 8:00 AM - 6:30 PM
| Atlanta, GA | USD $1195.00* | Enroll |
- Apr 29, 2019 8:00 AM - 5:30 PM
- Apr 30, 2019 8:00 AM - 6:30 PM
| Dallas, TX | USD $1195.00* | Enroll |
- May 06, 2019 8:00 AM - 5:30 PM
- May 07, 2019 8:00 AM - 6:30 PM
| San José, CA | USD $1195.00* | Enroll |
- May 13, 2019 8:00 AM - 5:30 PM
- May 14, 2019 8:00 AM - 6:30 PM
| Princeton, NJ | USD $1195.00* | Enroll |
- May 28, 2019 8:00 AM - 5:30 PM
- May 29, 2019 8:00 AM - 6:30 PM
| Minneapolis, MN | USD $1195.00* | Enroll |
- Jun 03, 2019 8:00 AM - 5:30 PM
- Jun 04, 2019 8:00 AM - 6:30 PM
| Atlanta, GA | USD $1195.00* | Enroll |
- Jun 10, 2019 8:00 AM - 5:30 PM
- Jun 11, 2019 8:00 AM - 6:30 PM
| Dallas, TX | USD $1195.00* | Enroll |
- Jun 10, 2019 8:00 AM - 5:30 PM
- Jun 11, 2019 8:00 AM - 6:30 PM
| San Diego, CA | USD $1195.00* | Enroll |
- Jun 17, 2019 8:00 AM - 5:30 PM
- Jun 18, 2019 8:00 AM - 6:30 PM
| Orlando, FL | USD $1195.00* | Enroll |
- Jun 24, 2019 8:00 AM - 5:30 PM
- Jun 25, 2019 8:00 AM - 6:30 PM
| Chicago, IL | USD $1195.00* | Enroll |
- Jul 08, 2019 8:00 AM - 5:30 PM
- Jul 09, 2019 8:00 AM - 6:30 PM
| Boston, MA | USD $1195.00* | Enroll |
- Jul 15, 2019 8:00 AM - 5:30 PM
- Jul 16, 2019 8:00 AM - 6:30 PM
| San Diego, CA | USD $1195.00* | Enroll |
- Jul 22, 2019 8:00 AM - 5:30 PM
- Jul 23, 2019 8:00 AM - 6:30 PM
| Dulles, VA | USD $1195.00* | Enroll |
- Jul 29, 2019 8:00 AM - 5:30 PM
- Jul 30, 2019 8:00 AM - 6:30 PM
| Seattle, WA | USD $1195.00* | Enroll |
- Aug 05, 2019 8:00 AM - 5:30 PM
- Aug 06, 2019 8:00 AM - 6:30 PM
| Atlanta, GA | USD $1195.00* | Enroll |
- Aug 19, 2019 8:00 AM - 5:30 PM
- Aug 20, 2019 8:00 AM - 6:30 PM
| Minneapolis, MN | USD $1195.00* | Enroll |
- Aug 19, 2019 8:00 AM - 5:30 PM
- Aug 20, 2019 8:00 AM - 6:30 PM
| San José, CA | USD $1195.00* | Enroll |
- Aug 26, 2019 8:00 AM - 5:30 PM
- Aug 27, 2019 8:00 AM - 6:30 PM
| Princeton, NJ | USD $1195.00* | Enroll |
- Sep 16, 2019 8:00 AM - 5:30 PM
- Sep 17, 2019 8:00 AM - 6:30 PM
| San Diego, CA | USD $1195.00* | Enroll |
- Sep 23, 2019 8:00 AM - 5:30 PM
- Sep 24, 2019 8:00 AM - 6:30 PM
| Dallas, TX | USD $1195.00* | Enroll |
- Sep 30, 2019 8:00 AM - 5:30 PM
- Oct 01, 2019 8:00 AM - 6:30 PM
| Atlanta, GA | USD $1195.00* | Enroll |
- Oct 07, 2019 8:00 AM - 5:30 PM
- Oct 08, 2019 8:00 AM - 6:30 PM
| Chicago, IL | USD $1195.00* | Enroll |
- Oct 21, 2019 8:00 AM - 5:30 PM
- Oct 22, 2019 8:00 AM - 6:30 PM
| Orlando, FL | USD $1195.00* | Enroll |
- Oct 21, 2019 8:00 AM - 5:30 PM
- Oct 22, 2019 8:00 AM - 6:30 PM
| Seattle, WA | USD $1195.00* | Enroll |
- Oct 21, 2019 8:00 AM - 5:30 PM
- Oct 22, 2019 8:00 AM - 6:30 PM
| San José, CA | USD $1195.00* | Enroll |
- Nov 04, 2019 8:00 AM - 5:30 PM
- Nov 05, 2019 8:00 AM - 6:30 PM
| San Diego, CA | USD $1195.00* | Enroll |
- Nov 18, 2019 8:00 AM - 5:30 PM
- Nov 19, 2019 8:00 AM - 6:30 PM
| Boston, MA | USD $1195.00* | Enroll |
- Dec 02, 2019 8:00 AM - 5:30 PM
- Dec 03, 2019 8:00 AM - 6:30 PM
| Atlanta, GA | USD $1195.00* | Enroll |
- Dec 02, 2019 8:00 AM - 5:30 PM
- Dec 03, 2019 8:00 AM - 6:30 PM
| San José, CA | USD $1195.00* | Enroll |
- Dec 16, 2019 8:00 AM - 5:30 PM
- Dec 17, 2019 8:00 AM - 6:30 PM
| Dulles, VA | USD $1195.00* | Enroll |