ISO 14971
Implement robust and effective processes for medical device and IVD risk management. Be aligned with the requirements and best practices of the ISO 14971 standard, ensuring the safety and effectiveness of your products throughout their entire life cycle.
Know more about ISO 14971 compliance software
Automation and standardization of processes
- Centralize all stages of risk management, from identification to continuous monitoring, on a single, integrated platform;
- Reduce manual errors;
- Achieve greater operational efficiency through processes that are in line with the ISO 14971 risk management standard.
Proactive risk mitigation and traceability
- Use advanced tools to identify potential risks and assess them;
- Implement corrective and preventive actions associated with the risk plan;
- Have full traceability of documented analyses;
- Ensure that all information is organized and accessible for inspections and audits;
- Reduce the effort required to demonstrate compliance with ISO 14971 certification.
Customizable analytics for decision-making
- Control and monitor risks;
- Generate detailed reports and dynamic dashboards;
- Manage risk processes in real time;
- Have a clear view of performance and indicators;
- Make strategic decisions based on data.
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Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance
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