Risk Management Automation

Compliance with ISO 14971:2019 in a Single System

fmea risk management iso 14971 dashboard

Compliance with ISO 14971:2019 requires medical device manufacturers to not only take a proactive attitude to risk management but also understand the perceived risks attached to the medical device itself. The concept of risk has two components; the probability of occurrence of harm and the consequences of that harm, both of which have varying degrees of severity.

Orcanos Risk Management has been designed to guide medical device manufacturers along the right path to compliance in a single workflow. Risk management is an accepted part of any product lifecycle, but the identification, tracking and mitigation of potential risks can become lost in paper-based and disparate systems.

Our system brings design control, risk and quality management into one integrated solution. By combining all the necessary elements for ISO 14971:2019 compliance into a centralized location, medical device manufacturers can reduce the risk of failure, ensure potential hazards are mitigated and prevent the occurence or consequences of harm.

Key Benefits & Features

Application Lifecycle Management Software

Integrated Solution

One single repository for Design Control, Risk and Quality Management

One-Click Risk Management File

Generating a digital Risk Management File that is compliant with regulatory standards can be done with a single click

End To End Traceability

Mitigation and impact analysis for Design Control elements are fully visible to end users and stakeholders

Cloud-based Solution

Our automated and cloud-based solution is available to access anywhere and at any time

Easy Setup

Configuration of your Risk Management processes can be completed in minutes


The Orcanos Risk Management tool essentially connects two different modules within the compliance process: Design Control (ALM) and Quality Management

The key to effective Risk Management is to reduce the level of risk that can impact an organization. More often that not, this relies heavily on knowing when a potential problem is about to happen. 

Orcanos’ Risk Management system has an integrated alert mechanism that notifies end users and stakeholders about any anomalies in the compliance process, generating a breakdown of impact analysis and actionable insights.

Tracked elements include:

  • Product complaints that have an associated risk, without any defined risk at that moment
  • Risk without mitigation
  • Test cases connected to risk mitigations that failed and which generated a level of risk
integrated design control , risk and qms


The Orcanos Risk Management tool can be customized to identify and highlight applicable risk elements in a medical device. This customization includes but is not limited to:

  • Acceptable and desirable levels of risk within each product/component
  • RPN (Criticality) Calculation
  • Naming risk elements, such as who is affected and the mitigation type
  • Setting up of multiple risk categories according to ISO 14971:2019


Risk assessments can be triggered from any associated Orcanos module and can be traced back to any defined work process. These include: 

  • Risk Control: Companies can integrate the definition and implementation of risk mitigation plans. For example, the tool can help define which control elements are required for a specific risk and assign action items. 
  • Risk Verification: Test cases can be tracked and traced to ensure that the level of risk has been properly assessed and verified, with these results saved for potential verification evidence
Requirements Verification Traceability Matrix
Track and Report


Orcanos Risk Management software includes a risk-based dashboard and access to analytic reports that can define a risk threshold.These embedded features can not only help trigger risk alerts and reports, but also increase team awareness of a product issue. 

In addition, the  in-built Document Generation tool will generate an RMF document ensuring automatic traceability that eliminates human error. This document can then be uploaded into the Orcanos e-DMS system for approval and e-signature.



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