Risk Management Automation

ISO 14971:2019 Compliance. Trace to design control mitigations


Orcanos Risk Management is designed to help medical device manufacturers to identify, track, and mitigate potential risks before they happen..

By using one system that connects design control, risk, and Quality Management, you can reduce risk of failure, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971:2019

Key Benefits & Features

Integrated Solution
Single repository for Risk, Design Control and Quality Management

Risk Management File
Generate Risk Management File in one click, ready for submission

End To End Traceability
Traceability To Design Control For Mitigation and impact analysis

Completely Online
The automated cloud solution for medical device, accessible anywhere, anytime

Easy Setup
It takes minutes to configure your risk management in Orcanos

Orcanos Risk Management Tool is actually the connecting part between the Design Control (ALM) and Quality Management modules.

In order to actively reduce your organization risk, Orcanos risk management system has a scheduled alert mechanism that notifies you about anomalies in the process, and impact analysis information.

What you can track for example:

  • Complaints that have risk association, without any traced risk
  • Risk without mitigation traceability
  • Test cases related to risk that have failed

Use Orcanos risk management setup for customizing risk settings, such as acceptable and desirable levels of risk, RPN calculation method, naming and special risk attributes, such as “who is affected”, “mitigation type”, setup multiple risk categories and more. Risk assessments can be triggered from any Orcanos module and can be traced to any work item.

Risk Control: Handle the definition and implementation of risk mitigation plans – define which controls are required for the specific risk, and action items, etc.

Risk Verification: Trace test cases to risk in order to assure risk is properly verified. Save results for verification evidence.

The Orcanos risk management software has a strong risk based dashboard as well as analytic reports that allow defining threshold, that later can trigger alerts and reports to increase team awareness.

Orcanos | DocGen utility generate your RMF document with the full FMEA table and traceability automatically with no human error, ready for upload into Orcanos e-DMS system for approval using e-signature feature.

Related links

  • Risk Management form according to ISO 14971
  • Risk management terminology
  • FMEA Risk management best practice (ISO 14971)
  • QRCANOS Requirements Management