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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

You will have the option to receive your course materials in either hard copy or soft copy:

  • Hard Copy option: You will receive a physical copy of the Student Handbook in the mail prior to the course.
  • Soft Copy option: You will receive an email prior to the course 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.

Course Logistics

  • Students need to connect to the class from any internet accessible location.
  • Webcam and Microphone are REQUIRED.
  • ALL course times shown are US EASTERN TIME.

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.

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
  • 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 Online - Half DayUSD $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 Online - Half DayUSD $1395.00Enroll
  • Jul 06, 2020 2:00 PM - 6:00 PM
  • Jul 07, 2020 2:00 PM - 6:00 PM
  • Jul 08, 2020 2:00 PM - 6:00 PM
  • Jul 09, 2020 2:00 PM - 6:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Jul 27, 2020 9:00 AM - 1:00 PM
  • Jul 28, 2020 9:00 AM - 1:00 PM
  • Jul 29, 2020 9:00 AM - 1:00 PM
  • Jul 30, 2020 9:00 AM - 1:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Aug 10, 2020 2:00 PM - 6:00 PM
  • Aug 11, 2020 2:00 PM - 6:00 PM
  • Aug 12, 2020 2:00 PM - 6:00 PM
  • Aug 13, 2020 2:00 PM - 6:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Aug 24, 2020 2:00 PM - 6:00 PM
  • Aug 25, 2020 2:00 PM - 6:00 PM
  • Aug 26, 2020 2:00 PM - 6:00 PM
  • Aug 27, 2020 2:00 PM - 6:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Sep 14, 2020 2:00 PM - 5:00 PM
  • Sep 15, 2020 2:00 PM - 5:00 PM
  • Sep 16, 2020 2:00 PM - 5:00 PM
  • Sep 17, 2020 2:00 PM - 5:00 PM
  • Sep 18, 2020 2:00 PM - 5:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Sep 28, 2020 9:00 AM - 12:00 PM
  • Sep 29, 2020 9:00 AM - 12:00 PM
  • Sep 30, 2020 9:00 AM - 12:00 PM
  • Oct 01, 2020 9:00 AM - 12:00 PM
  • Oct 02, 2020 9:00 AM - 12:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Oct 19, 2020 9:00 AM - 12:00 PM
  • Oct 20, 2020 9:00 AM - 12:00 PM
  • Oct 21, 2020 9:00 AM - 12:00 PM
  • Oct 22, 2020 9:00 AM - 12:00 PM
  • Oct 23, 2020 9:00 AM - 12:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Nov 09, 2020 9:00 AM - 12:00 PM
  • Nov 10, 2020 9:00 AM - 12:00 PM
  • Nov 11, 2020 9:00 AM - 12:00 PM
  • Nov 12, 2020 9:00 AM - 12:00 PM
  • Nov 13, 2020 9:00 AM - 12:00 PM
Live Online - Half DayUSD $1395.00Enroll
  • Dec 07, 2020 2:00 PM - 5:00 PM
  • Dec 08, 2020 2:00 PM - 5:00 PM
  • Dec 09, 2020 2:00 PM - 5:00 PM
  • Dec 10, 2020 2:00 PM - 5:00 PM
  • Dec 11, 2020 2:00 PM - 5:00 PM
Live Online - Half DayUSD $1395.00Enroll