ISO 13485:2016 Requirements (TPECS)

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.

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

Course Materials

Students receive comprehensive course manuals with reference materials.

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. 

Class Logistics

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.

Upcoming Course Dates

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