ISO 14791

The requirements for medical devices, including the Medical Device Directive (93/42/EEC), the In-Vitro Diagnostics Directive (98/79/EC) and the Active Implantable Medical Device Directive (90/385/EEC), detail requirements for risk management.

ISO 14971 harmonises global regulations for risk management. This means meeting the requirements of the standard can help you to demonstrate compliance.

Our software helps you manage risks, identify issues and get more data from your management systems.

Complex circle

Medical device risk management best practice.

Be confident in your approach.

Confidence you're following best practice

Easy-to-manage speed and cost to get your medical devices to market.

Systematically identify risks

Manage foreseeable hazards, customer complaints and create vigilance reports.

Streamline the regulatory process

Associate documentation, risks, issues and training records in a central system.

Evaluate risk classes

Document likelihood and severity and manage associated issues, workflows and escalation paths.

Mitigate risks

Assign responsibility and ownership for risks in production, IFU and training.

Integrate with other standards

Associate risks with standards such as ISO 13485 to reduce duplication of effort.

Integrated modules for ISO 14791

Modules work well on their own or in harmony together.
Audit management software
Audit management software
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Accident & incident management software
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Document control software
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