How to implement product management risk management with ISO 14971 for medical device manufacturers?
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While quality and risk management systems are also examples of management systems on their own, combining them into a single, integrated system is the best way to go. If you have an ISO 13485 Quality Management System or a certificate, we can help you integrate ISO 14971 into your existing Quality Management System. Our application consists of two parts:
Turkish: GAP Analysis
Our expert staff conducts an on-site review of your current thinking and risk management to analyze your current level of compliance with ISO 14971. It provides a GAP Analysis Report that expresses the requirements.
Creating a Risk Management and Risk Management File
Based on our GAP analysis and its components for your organization's device type, a system is designed for risk management awards and risk assessment of ISO 14971 requirements.
If you have a separate risk management and quality management system, the two-part process is applied for compliance with ISO 14971. Alternatively, the director may set up a review and support team for risk analysis, post-market monitoring, etc.
Once your risk management system is in place, it is critical to ensure that all your staff understand how they can contribute to effective risk management. To learn about the use and implementation of comprehensive risk management software, follow these steps:
