ISO 13485 TRAINING – VIRTUAL

  • Delivery Option: Public & On-Site
  • Subject Category: Auditing
  • Number of Days: See # of Sessions for each Class

Course Summary

Understand the requirements of ISO 13485:2016 and the evidence to demonstrate conformance. Learn how it compares to 21 CFR 820 and ISO 9001:2015. Led by our experienced trainers, the courses include hands-on workshops in an engaging and collaborative learning environment. Please see available dates for each class on our registration page.

The virtual classes are certified by Exemplar Global and qualify for early registration and multiple attendee discounts

System Requirements

  • Operating System: Windows 7 and up; or MAC OS X 10.13 and up;
  • High-speed internet connection (2.5 Mbps download, 3.0 Mbps upload)
  • Speakerphone or computer audio (VOIP). A telephone headset is recommended for optimal audio quality
  • Webcam is required to take an online proctored exam.

ISO 13485:2016 Lead Auditor$1695 – Eight 4-hour sessions

  • Fully understand and interpret the requirements of ISO 13485:2016
  • Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
  • Understand how to apply the requirements of the ISO 13485:2016 standard
  • Conduct practical audit exercises to apply these requirements and manage the audit process in a collaborative and engaging environment.

This course has been specifically designed to meet the needs of the Medical Device Industry.

The instructor-led, virtual course is delivered in 8 convenient, 4-hour sessions spread over 2 weeks.  Schedule a proctored, online exam within 3 days of completing each unit to receive the documentation required for full certification.

  • Week 1

Mon-Thu (9 am-1 pm Central Time)
ISO 13485:2016 (Competency Unit MD)

  • Week 2

Mon-Tue (9 am – 1pm Central Time)
Management Systems Auditing (Competency Unit AU)

Wed-Thu (9 am-1pm Central Time)
Leading Management Systems Audit Teams (Competency Unit TL)

View face-to-face Classroom dates here.

ISO 9001:2015 Internal Auditor$1195 Six 4-hour sessions

  • Fully understand and successfully interpret the ISO 13485 requirements
  • Understand how to audit using the process approach
  • Ask audit questions that get results

 

The instructor-led, virtual course is delivered in 6 convenient, 4-hour sessions spread over 2 weeks. There is an online exam for each competency unit to be completed within 3 days of completing each unit to receive the documentation required for full certification.

  • Week 1

Mon-Thu (9 am-1 pm Central Time)
ISO 13485:2016 (Competency Unit MD)

  • Week 2

Mon-Tue (9 am – 1 pm Central Time)
Management systems auditing (Unit AU)

 View face-to-face Classroom dates here.

Target Audience

Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process.

Prerequisites

All attendees are required to have their own copy of the ISO 13485:2016 standard.

Course Objectives

These ISO 13485:2015 standard training classes will be delivered in an instructor-led online format. After you register for a virtual course, you will receive a confirmation email with instructions on how to join the session. You will also get a reminder 24 hours before the class begins.