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.

Solve your challenges

Ensure that risks associated with the product lifecycle are consistently identified, assessed, mitigated, and documented.

Maintain a clear and traceable history of risk analyses and their updates over time, especially during changes in design or manufacturing processes.

Meet stringent regulatory requirements that demand detailed documentation and standardized risk management processes.

Know more about ISO 14971 compliance software

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.

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.

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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Glossary

Codex Alimentarius

A collection of international food standards, guidelines, and codes of practice aimed at promoting food safety, protecting consumer health, and facilitating international food trade by ensuring the harmonization of food regulations and standards worldwide.

Compliance

Adherence to legal, regulatory, customer, and internal requirements.

ABNT (Brazilian Association of Technical Standards)

Founded in 1940, this organization is responsible for technical standardization in Brazil. Its standards aim to standardize processes, products, and services to ensure greater quality, safety, and efficiency.

Secure, compliant, and ready to integrate with your ecosystem

Built to connect with your existing stack while keeping governance, traceability, and control at the center.

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