Implementation of ISO 13485 MasterClass

  • 10-11 Oct 2022
  • Online Event

Description

The Implementation of ISO 13485 MasterClass is dedicated to the basic principles of a quality management system.

The Implementation of ISO 13485 MasterClass covers topics such as:

  • Understanding the basic principles of a quality management system
  • Gaining an understanding of the relationship between standards and quality management systems
  • Identifying the critical elements of a quality system
  • Incorporating the Plan-Do-Check-Act approach
  • Assessing and applying risk throughout the quality system
  • Creating a documentation structure that is consistent with the system requirements
  • Understanding the differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016
  • Comparing the requirements of ISO 13485 to the FDA QSR
  • Establishing a plan for implementing the revised requirements of ISO 13485: 2016
  • Understanding the QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016

The Implementation of ISO 13485 MasterClass brings together:

  • Quality managers
  • Quality associates
  • Project Managers
  • Document Control coordinators
  • Middle management in regulated industries
  • Regulatory Affairs professionals
  • Independent service organizations

Past Events

Important

Please, check "Implementation of ISO 13485 MasterClass" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance
Government & Global Issues: Law & Regulations
Health & Medicine: Pharma

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