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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 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

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. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class “Essentials of ISO 13485:2003” prior to attending the classroom training.

Course Materials

Students will receive a BSI Connected Learning Live course kit that will include:

·         Course kit instructions

·         LogitechTM headphone set with microphone

·         LogitechTM high-definition web cam

·         Comprehensive course manual with reference materials

·         Contact information for technical support

Course Logistics:

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

*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 09, 2018 2:00 PM - 5:00 PM
  • Jul 10, 2018 2:00 PM - 5:00 PM
  • Jul 11, 2018 2:00 PM - 5:00 PM
  • Jul 12, 2018 2:00 PM - 5:00 PM
  • Jul 13, 2018 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Aug 13, 2018 2:00 PM - 5:00 PM
  • Aug 14, 2018 2:00 PM - 5:00 PM
  • Aug 15, 2018 2:00 PM - 5:00 PM
  • Aug 16, 2018 2:00 PM - 5:00 PM
  • Aug 17, 2018 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Sep 10, 2018 2:00 PM - 5:00 PM
  • Sep 11, 2018 2:00 PM - 5:00 PM
  • Sep 12, 2018 2:00 PM - 5:00 PM
  • Sep 13, 2018 2:00 PM - 5:00 PM
  • Sep 14, 2018 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Sep 24, 2018 2:00 PM - 5:00 PM
  • Sep 25, 2018 2:00 PM - 5:00 PM
  • Sep 26, 2018 2:00 PM - 5:00 PM
  • Sep 27, 2018 2:00 PM - 5:00 PM
  • Sep 28, 2018 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll
  • Oct 15, 2018 9:00 AM - 12:00 PM
  • Oct 16, 2018 9:00 AM - 12:00 PM
  • Oct 17, 2018 9:00 AM - 12:00 PM
  • Oct 18, 2018 9:00 AM - 12:00 PM
  • Oct 19, 2018 9:00 AM - 12:00 PM
Live OnlineUSD $1395.00Enroll
  • Oct 29, 2018 9:00 AM - 12:00 PM
  • Oct 30, 2018 9:00 AM - 12:00 PM
  • Oct 31, 2018 9:00 AM - 12:00 PM
  • Nov 01, 2018 9:00 AM - 12:00 PM
  • Nov 02, 2018 9:00 AM - 12:00 PM
Live OnlineUSD $1395.00Enroll
  • Nov 26, 2018 2:00 PM - 5:00 PM
  • Nov 27, 2018 2:00 PM - 5:00 PM
  • Nov 28, 2018 2:00 PM - 5:00 PM
  • Nov 29, 2018 2:00 PM - 5:00 PM
  • Nov 30, 2018 2:00 PM - 5:00 PM
Live OnlineUSD $1395.00Enroll