Course Details

Connected Learning Live ISO 13485:2016 Requirements (TPECS)

Course Area

Medical Devices

Continuing Education Units

1.6

Course Fee

USD $1295.00

Upcoming Sessions
Jan 25-28, 2021 - Live Online - Half DayEnroll
Feb 1-2, 2021 - Live Online - Full DayEnroll
Feb 8-9, 2021 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

Course Details

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 four, 4 hour sessions*, one per day. There are online exams at the end of each competency unit, which is in session 4. 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 Upcoming Course Dates

Date and Time Location Fees Enroll
Jan 25, 2021 2:30 PM - 6:30 PM ET
Jan 26, 2021 2:30 PM - 6:30 PM ET
Jan 27, 2021 2:30 PM - 6:30 PM ET
Jan 28, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Feb 1, 2021 9:00 AM - 5:30 PM ET
Feb 2, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 8, 2021 11:00 AM - 8:30 PM ET
Feb 9, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 8, 2021 2:30 PM - 6:30 PM ET
Feb 9, 2021 2:30 PM - 6:30 PM ET
Feb 10, 2021 2:30 PM - 6:30 PM ET
Feb 11, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Feb 15, 2021 9:00 AM - 5:30 PM ET
Feb 16, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 22, 2021 11:00 AM - 8:30 PM ET
Feb 23, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Feb 22, 2021 2:30 PM - 6:30 PM ET
Feb 23, 2021 2:30 PM - 6:30 PM ET
Feb 24, 2021 2:30 PM - 6:30 PM ET
Feb 25, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Mar 1, 2021 9:00 AM - 5:30 PM ET
Mar 2, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 8, 2021 11:00 AM - 8:30 PM ET
Mar 9, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 8, 2021 2:30 PM - 6:30 PM ET
Mar 9, 2021 2:30 PM - 6:30 PM ET
Mar 10, 2021 2:30 PM - 6:30 PM ET
Mar 11, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Mar 15, 2021 9:00 AM - 5:30 PM ET
Mar 16, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 22, 2021 11:00 AM - 8:30 PM ET
Mar 23, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Mar 22, 2021 2:30 PM - 6:30 PM ET
Mar 23, 2021 2:30 PM - 6:30 PM ET
Mar 24, 2021 2:30 PM - 6:30 PM ET
Mar 25, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Mar 29, 2021 9:00 AM - 5:30 PM ET
Mar 30, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 6, 2021 11:00 AM - 8:30 PM ET
Apr 7, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 6, 2021 2:30 PM - 6:30 PM ET
Apr 7, 2021 2:30 PM - 6:30 PM ET
Apr 8, 2021 2:30 PM - 6:30 PM ET
Apr 9, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Apr 12, 2021 9:00 AM - 5:30 PM ET
Apr 13, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 19, 2021 11:00 AM - 8:30 PM ET
Apr 20, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Apr 19, 2021 2:30 PM - 6:30 PM ET
Apr 20, 2021 2:30 PM - 6:30 PM ET
Apr 21, 2021 2:30 PM - 6:30 PM ET
Apr 22, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Apr 26, 2021 9:00 AM - 5:30 PM ET
Apr 27, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 3, 2021 11:00 AM - 8:30 PM ET
May 4, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 3, 2021 2:30 PM - 6:30 PM ET
May 4, 2021 2:30 PM - 6:30 PM ET
May 5, 2021 2:30 PM - 6:30 PM ET
May 6, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
May 10, 2021 9:00 AM - 5:30 PM ET
May 11, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 17, 2021 11:00 AM - 8:30 PM ET
May 18, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
May 17, 2021 2:30 PM - 6:30 PM ET
May 18, 2021 2:30 PM - 6:30 PM ET
May 19, 2021 2:30 PM - 6:30 PM ET
May 20, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
May 24, 2021 9:00 AM - 5:30 PM ET
May 25, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jun 7, 2021 11:00 AM - 8:30 PM ET
Jun 8, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jun 7, 2021 2:30 PM - 6:30 PM ET
Jun 8, 2021 2:30 PM - 6:30 PM ET
Jun 9, 2021 2:30 PM - 6:30 PM ET
Jun 10, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Jun 14, 2021 9:00 AM - 5:30 PM ET
Jun 15, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jun 21, 2021 11:00 AM - 8:30 PM ET
Jun 22, 2021 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1295.00Enroll
Jun 21, 2021 2:30 PM - 6:30 PM ET
Jun 22, 2021 2:30 PM - 6:30 PM ET
Jun 23, 2021 2:30 PM - 6:30 PM ET
Jun 24, 2021 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1295.00Enroll
Jun 28, 2021 9:00 AM - 5:30 PM ET
Jun 29, 2021 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1295.00Enroll

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

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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