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Connected Learning Live ISO 13485:2016 Requirements (TPECS)

BSI Connected Learning Live is a live, online training that combines premier skills development technologies with our expert instructors to deliver an engaging, interactive learning experience to you, regardless of location. This is an ideal alternative to the typical classroom setting for quality professionals who do not have the budget or time for travel, or just prefer the convenience of attending a class without having to leave their own personal environment

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:

Students receive comprehensive course manuals with reference materials.

Course Logistics:

Students can connect to the class from any internet-accessible location. Chrome is preferred. 

Students will require a Webcam and a Microphone. 

There are five 3 hour sessions*, one per day. There are online exams at the end of each competency unit, which is in sessions 5. Each exam is 90 minutes. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed "Competent" for each. Certificates of Attendance are provided to those who do not pass the competency exam(s), and students will be given the opportunity to retake the test(s)

*Session lengths could vary depending on amount of class discussion.

*****All course times shown are Eastern Time.*****

Upcoming Course Dates

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

Start/End Date and Time Location Fee Enroll
  • Oct 21, 2019 9:00 AM - 12:00 PM
  • Oct 22, 2019 9:00 AM - 12:00 PM
  • Oct 23, 2019 9:00 AM - 12:00 PM
  • Oct 24, 2019 9:00 AM - 12:00 PM
  • Oct 25, 2019 9:00 AM - 12:00 PM
Live OnlineUSD $1395.00Enroll
  • Nov 11, 2019 2:00 PM - 5:00 PM
  • Nov 12, 2019 2:00 PM - 5:00 PM
  • Nov 13, 2019 2:00 PM - 5:00 PM
  • Nov 14, 2019 2:00 PM - 5:00 PM
  • Nov 15, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Dec 09, 2019 2:00 PM - 5:00 PM
  • Dec 10, 2019 2:00 PM - 5:00 PM
  • Dec 11, 2019 2:00 PM - 5:00 PM
  • Dec 12, 2019 2:00 PM - 5:00 PM
  • Dec 13, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Jan 06, 2020 2:00 PM - 5:00 PM
  • Jan 07, 2020 2:00 PM - 5:00 PM
  • Jan 08, 2020 2:00 PM - 5:00 PM
  • Jan 09, 2020 2:00 PM - 5:00 PM
  • Jan 10, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Feb 03, 2020 2:00 PM - 5:00 PM
  • Feb 04, 2020 2:00 PM - 5:00 PM
  • Feb 05, 2020 2:00 PM - 5:00 PM
  • Feb 06, 2020 2:00 PM - 5:00 PM
  • Feb 07, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Mar 02, 2020 2:00 PM - 5:00 PM
  • Mar 03, 2020 2:00 PM - 5:00 PM
  • Mar 04, 2020 2:00 PM - 5:00 PM
  • Mar 05, 2020 2:00 PM - 5:00 PM
  • Mar 06, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Mar 16, 2020 9:00 AM - 12:00 PM
  • Mar 17, 2020 9:00 AM - 12:00 PM
  • Mar 18, 2020 9:00 AM - 12:00 PM
  • Mar 19, 2020 9:00 AM - 12:00 PM
  • Mar 20, 2020 9:00 AM - 12:00 PM
Live OnlineUSD $1395.00Enroll
  • Mar 30, 2020 2:00 PM - 5:00 PM
  • Mar 31, 2020 2:00 PM - 5:00 PM
  • Apr 01, 2020 2:00 PM - 5:00 PM
  • Apr 02, 2020 2:00 PM - 5:00 PM
  • Apr 03, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Apr 20, 2020 2:00 PM - 5:00 PM
  • Apr 21, 2020 2:00 PM - 5:00 PM
  • Apr 22, 2020 2:00 PM - 5:00 PM
  • Apr 23, 2020 2:00 PM - 5:00 PM
  • Apr 24, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • May 04, 2020 9:00 AM - 12:00 PM
  • May 05, 2020 9:00 AM - 12:00 PM
  • May 06, 2020 9:00 AM - 12:00 PM
  • May 07, 2020 9:00 AM - 12:00 PM
  • May 08, 2020 9:00 AM - 12:00 PM
Live OnlineUSD $1395.00Enroll
  • May 18, 2020 9:00 AM - 12:00 PM
  • May 19, 2020 9:00 AM - 12:00 PM
  • May 20, 2020 9:00 AM - 12:00 PM
  • May 21, 2020 9:00 AM - 12:00 PM
  • May 22, 2020 9:00 AM - 12:00 PM
Live OnlineUSD $1395.00Enroll
  • Jun 01, 2020 2:00 PM - 5:00 PM
  • Jun 02, 2020 2:00 PM - 5:00 PM
  • Jun 03, 2020 2:00 PM - 5:00 PM
  • Jun 04, 2020 2:00 PM - 5:00 PM
  • Jun 05, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Jun 15, 2020 2:00 PM - 5:00 PM
  • Jun 16, 2020 2:00 PM - 5:00 PM
  • Jun 17, 2020 2:00 PM - 5:00 PM
  • Jun 18, 2020 2:00 PM - 5:00 PM
  • Jun 19, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll