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Connected Learning Live ISO 13485:2016 Requirements (TPECS)

The class is not currently available.

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
  • Jul 22, 2019 9:00 AM - 12:00 PM
  • Jul 23, 2019 9:00 AM - 12:00 PM
  • Jul 24, 2019 9:00 AM - 12:00 PM
  • Jul 25, 2019 9:00 AM - 12:00 PM
  • Jul 26, 2019 9:00 AM - 12:00 PM
Live OnlineUSD $1395.00Enroll
  • Aug 19, 2019 2:00 PM - 5:00 PM
  • Aug 20, 2019 2:00 PM - 5:00 PM
  • Aug 21, 2019 2:00 PM - 5:00 PM
  • Aug 22, 2019 2:00 PM - 5:00 PM
  • Aug 23, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • 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
  • 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