Understanding ISO 13485:2016 Requirements (Remote)

Live, instructor-led, remote training that provides a detailed and thorough understanding of the ISO 13485:2016 requirements for medical device quality management.

Duration: 8 Hours (2 Sessions of 4.0 Hours)

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Course Description

Live, instructor-led remote training that provides a thorough review of the ISO 13485:2016 requirements for medical device quality management. Participants will gain a detailed understanding of the standard’s requirements, as well as the principles that support a management system

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485:2016 QMS.  This includes, but is not limited to:

  • Those responsible for implementing their organization’s QMS to meet the ISO 13485:2016 requirements.
  • Senior Management
  • ISO Coordinators, Quality Managers & Management Representatives
  • Members of the Quality Team and/or Internal Audit Team
  • ISO 13485 Auditors, Quality Professionals and Consultants

Course Content

  • Introduction to ISO 13485:2016 – Quality management for medical devices.
  • ISO 13485:2016 – Scope, Normative References, Terms and Conditions
  • ISO 13485:2016 – Section 4: Quality Management System
  • ISO 13485:2016 – Section 5: Management Responsibility
  • ISO 13485:2016 – Section 6: Resources
  • ISO 13485:2016 – Section 7: Product Realization
  • ISO 13485:2016 – Section 8: Measurement, Analysis and Improvement

Prerequisites

This is an introductory course.  However, participants will benefit from previous experience working with, or within, an ISO 13485 quality management system.

Additional information

Delivery Method

Remote

Course Types

Understanding Requirements

Sectors

Medical Devices (ISO 13485, ISO 14971)

Open or Dedicated

Open Enrolment, Dedicated Session

Dates

Dates to come.

Location

Hours

Monday: 9am-5:30pm EST
Tuesday: 9am-5:30pm EST
Wednesday: 9am-5:30pm EST
Thursday: 9am-5:30pm EST
Friday: 9am-5:30pm EST
Saturday: CLOSED
Sunday: CLOSED