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
