Risk Management

Automate risk level calculations and configure probabilities based on hazardous situations. Stay informed and save time with a precise and efficient risk management solution.

Risk mitigation matrix of probability vs. severity
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Integrated Risk Management System

Seamlessly connect Design Control (ALM) and Quality Management modules, enabling effective risk reduction. Stay ahead by identifying potential issues before they arise.

A powerful integrated alert mechanism will keep end-users and stakeholders informed about compliance anomalies.
Gain actionable insights through impact analysis breakdowns. Track crucial elements with ease, including:

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Mitigation of product complaints and associate risks
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Addressing risks without defined mitigations
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Tracking and managing test cases connected to failed risk mitigations, ensuring effective risk management.

ISO 14971 Compliance

Compliance with ISO 14971:2019 medical device manufacturers are required to adopt a proactive approach to risk management associated with the medical device.
Our integrated solution simplifies risk management for medical device manufacturers, reducing failure risk, mitigating hazards, and ensuring compliance. Streamline your workflow and prevent harm or consequences.

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Take your regulatory compliance to the next level with Orcanos. Book a demo today and experience the power of our integrated solutions firsthand!

Our Risk Management has some more to offer

Risk Automation

Automate risk management effortlessly. Calculate risk levels, set probabilities based on hazards, and more.

Supports FMEA Types

Define PFMEA, UFMEA, DFMEA easily, setup different calculations and different methodology based on the FMEA type

Easy Customization

Set up electronic risk forms, define mandatory rules and access control, establish a workflow for sign off, and design the layout.

Cloud-based Solution

Our automated and cloud-based solution is available for access anywhere and at any time, serving as a compliance hub for your organization.

Track and Report

Orcanos Risk Management software provides a risk-based dashboard and analytical reports to define risk thresholds. Its embedded features trigger alerts and reports to increase team awareness of potential product issues. Furthermore, the built-in Document Generation tool automatically generates an RMF document, ensuring automatic traceability and eliminating human error. This document can then be uploaded into the Orcanos e-DMS system for approval and e-signature.

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