Integrated Risk Management System
The Orcanos Risk Management tool connects two modules within the compliance process: Design Control (ALM) and Quality Management.
Effective risk management requires reducing the level of risk that can impact an organization, which often relies on identifying potential problems before they occur.
To facilitate this, Orcanos' Risk Management system features an integrated alert mechanism that notifies end-users and stakeholders of any anomalies in the compliance process. This generates 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
ISO 14971 Compliance
Compliance with ISO 14971:2019 requires medical device manufacturers to adopt a proactive approach to risk management and comprehend the perceived risks associated with the medical device. The concept of risk comprises two components: the probability of occurrence of harm and the consequences of that harm, both of which can 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. While risk management is an integral part of any product lifecycle, the identification, tracking, and mitigation of potential risks can often be lost in paper-based and disparate systems.
Our system integrates design control, risk management, and quality management into a single, comprehensive solution. By consolidating all necessary elements for ISO 14971:2019 compliance into a centralized location, medical device manufacturers can reduce the risk of failure, mitigate potential hazards, and prevent harm occurrence or consequences.
Automate the entire risk management system, such as Risk Level calculation method, automatic setup of probability based on the Hazardous situation, and more.
Supports FMEA Types
Define PFMEA, UFMEA, DFMEA easily, setup different calculations and different methodology based on the FMEA type
Easily set up the electronic risk form, define mandatory rules and access control, establish a workflow for sign off, and design the layout.
Risk Management For Medical Device
The Orcanos Risk Management tool can be customized to identify and highlight applicable risk elements in a medical device. This customization includes:
- Displaying acceptable and desirable levels of risk within each product or component
- Automatic RPN (Criticality) Calculation
- Setting up of multiple risk categories according to ISO 14971:2019
Companies can integrate the definition and implementation of their risk mitigation plans into Orcanos
For example, the tool can help define which control elements are required for a specific risk, such as design artifacts.
Test cases can be tracked and traced to ensure that the level of risk has been properly assessed and verified, saving these results for potential verification evidence.
A Complete Solution
Integrate risk management into your development and Quality Management System (QMS) to ensure complete traceability and save up to 30% of the resources spent on manual management.
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
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.Schedule Demo
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What our client say about us
"Very good value for money, very helpful with preparations for audits"
Tsvika - System and Software QA Manager Medical Devices
I mainly used it for RISK management, and for PRD SRS and HRS documents requirements, including traceability to RISK. I also used it for Customer Complaints handling. Web based application is accesible from everywere by those who were defined by role. Everything is orgenized and traceable keeping changes history. It allows to keep implementation and testing coverage updated.
"Using ORCANOS for Medical Devices"
Gerd E - Lead System Architect
One database, one tool and user interface for requirement, risk , test, CAPA management etc. Item based! with the possibility to generate documents on each level. No need to manage interfaces , relatively fast to configure for own needs, without writing and validation of user-ware. 100% cloud based and platform independent.
"My major tool for conformity."
Stephen - QA Manager
The simple and easy way of controlling documentation. Time saving and ease when undergoing audits by Notified Bodies. Traceability when it comes to CAPA and ECO's.
"I love the flexibility of Orcanos!"
I love the flexibility of Orcanos! It feels like the system is almost 100% configurable, so whenever I think 'it would be nice to do this' then I can always do it within the system. The traceability function is awesome too, it means that we can link our items together so that we can get an overview of the project from top to bottom.
Technical Program Manager, Fio
The Orcanos medical ALM solution provides us with a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc.), risks management and traceability in a highly regulated environment.
Co-Founder, Mazor Robotics
Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…
…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…
Why you choose Orcanos
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FREQUENTLY ASK QUESTION
Want to ask something from us?
Yes, we would be happy to demonstrate Orcanos ALM through a web-conference at your convenience. The demo can take 45-60 minutes depending on your needs. To schedule a session, please contact us at [email protected].
We accept payment via credit cards, PayPal, and bank transfer.
For more details, please contact [email protected]
No. You can to select a package based on your needs (Design Control or QMS), where the Premium package includes EVERYTHING.
It means all users belong to the same package
Orcanos ALM is a pay-as-you-go service (monthly or yearly). This means there are no long-term contracts. You can choose to upgrade, downgrade, or cancel your subscription at any time by logging into your Orcanos ALM account or contact us by email at [email protected].
This is a set of validation documents (Requirements Spec, Test Design and Tst results) that you get along with our software, and on each upgrade. They are the proof that the software was validated, and that it is Part 11 Compliant
Your data safe and secured. Orcanos is hosted at AWS and apply the strictest security controls. We have a backup procedure running every 15 minutes. Backup snapshot is encrypted and stored on different servers.
Learn more about the Orcanos Security Center
Yes. If you wish to have users that are read only, it’s possible. Contact us for more details
Yes, you can. To switch plans, please contact us.
Yes, it is. You have a full validation package as part of Orcanos system.
No. One of Orcanos’ advantages, is that you have a virtual environment and YOU get to decide if and when to upgrade your account to a newer versions. This is most critical for regulated companies such as medical device manufacturers.