Risk Manager

Service Description

Objective: This training aims to identify the key requirements of risk management in accordance with ISO 14971:2019, and to interpret and apply the standard's main requirements and expectations within your organization. You will also gain an understanding of the links between ISO 14971:2019, ISO 13485:2016 and the regulations on medical devices 2017/745 (MDR) and in vitro diagnostic devices (IVDR). Have the tools needed to manage risk management, linking initial and residual risk analysis to requirements and mitigation measures, as well as to verification tests of the effectiveness of these actions and to other risks, all at a reasonable cost thanks to the Atlassian suite and its ecosystem. Target audience: Medical device industry professionals, including manufacturers, distributors and service providers. Persons responsible for regulatory compliance of medical devices (PRRC), quality managers, internal auditors and any team member involved in medical device quality management. Engineers, software developers, product designers and other professionals involved in the design and manufacturing of medical devices. Training program: - Identify the regulatory requirements for medical device risk management. - Implement the steps of the risk management process in accordance with ISO 14971. - Identification, analysis, evaluation and control of risks. - Evaluation of the overall residual risk. - Automatic calculation of the benefit/risk ratio for each identified risk. - Creating the essential documents (risk management plan, risk analysis matrix and risk management report) to ensure the compliance of risk management activities. - Brief practical overview of the tools used (the Atlassian suite and its ecosystems). - Practical application through concrete case studies.