Integrated Risk Management System
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
ISO 14971 Compliance
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.
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 clickSchedule Demo
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
Setup the risk electronic form easily, define mandatory rules and access control, workflow for sign off and layout
End To End Traceability
Mitigation and impact analysis for Design Control elements are fully visible to end users and stakeholders
Our automated and cloud-based solution is available to access anywhere and at any time, a Compliance Hub of your organizationSchedule Demo
Configuration of your Risk Management processes can be completed in minutes.
- Fields layout
- Mandatory rules
- Risk Level Calculation
- Workflows and Sign-off
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 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
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, such as design artifacts.
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
A Complete Solution
Integrate risk into your development, and to your QMS, to assure full traceability, and save 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 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.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.