Implementing ISO 14971:2012 training course

The course was developed to provide participants with the knowledge andtechniques to implement a Risk Management System associated with MedicalDevices in accordance with the requirements of ISO 14971: 2012, verifying theirimpact on decision-making processes.

The training session provides the skills necessary to develop and implement a riskmanagement system within the quality management system of medical devicesISO 13485: 2012.By participating in this course, you will learn how the application of ISO 14971gives presumption of conformity with the Essential Requirements of Directive93/42 / EEC and subsequent additions / modifications, bringing benefits for your business at the same time.

Who should attend?

  • Who have a basic understanding of quality managementsystems for Medical Devices companies and a generalfamiliarity with Medical Devices
  • Anyone involved in defining, planning, or implementing an ISO 14971: 2012 management system
  • Anyone is part of a team involved or responsible for ISO14971: 2012
  • You need to perform a gap assessment of RiskManagement System you have in place

What will I learn?

Upon completion of this training, delegates will be able to:
  • Understand the role of risk management in MedicalDevices companies
  • Learn the structure and purpose of ISO 14971 andthe areas of application of the standard within theorganization
  • Understand the implementation process in the organization
  • Provide a plan for implementing risk management
  • Prepare a risk analysis model appropriate to yourorganizational structure and to the type of medical devices you produce