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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 devices ISO 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.
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