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.
New to TPECS?
For more information, please see our Understanding the TPECS Course Structure page.
- 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
You will have the option to receive your course materials in the following formats:
- Hard Copies: At the start of the course, a physical copy of the Student Handbook will be provided.
- Soft Copies: Prior to the course, an email 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.
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
- Laboratory quality professionals
- Accredited auditors requiring the competency to audit Medical Device Systems
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.
Online course option
This Course is also available as part of BSI's Connected Learning Live service. A virtual instructor lead training course taught live online in a virtual classroom. Scheduled times and dates are available HERE
All Upcoming Course Dates
|Date and Time||Location||Fees||Enroll|
|Apr 12, 2021 8:00 AM - 5:30 PM|
Apr 13, 2021 8:00 AM - 6:30 PM
|Nashville, TN||USD $1295.00||Enroll|
|May 10, 2021 8:00 AM - 5:30 PM|
May 11, 2021 8:00 AM - 6:30 PM
|Dulles, VA||USD $1295.00||Enroll|
|Jun 14, 2021 8:00 AM - 5:30 PM|
Jun 15, 2021 8:00 AM - 6:30 PM
|Orlando, FL||USD $1295.00||Enroll|
The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.