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Our reviews on G2...

Orcanos is a leader in ALM Software Suites on G2 Orcanos is a leader in Mid-Market Quality Management (QMS) on G2 Orcanos is a leader in ALM Software Suites on G2 Orcanos is a leader in Medical QMS on G2 Orcanos is a leader in Medical QMS on G2 Orcanos is a leader in Quality Management (QMS) on G2

Integrating ALM and QMS

Are you struggling with a lack of communication flow between your R&D and QA departments?
We offer a secure, robust, and simple platform for managing compliance that integrates ALM and QMS to facilitate faster and smoother processes. By consolidating ALM and QMS processes in a single location, you can easily trace artifacts and interconnect cross-organizational processes. This holistic approach can shorten time to market, reduce costs, and prevent frustration. Our integrated approach is the first of its kind on the market, allowing companies to meet standards using a single system that benefits both the R&D and Quality teams.

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ISO 14971 Compliance with Orcanos Risk Automation

How much time is spent on manual traceability?

Safety is the key in Orcanos support for risk based development.
Integrating risk management into your development process and QMS ensures complete traceability and reduces manual management costs by 30%.

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Adaptive Compliance

Replace paper-based QMS with Orcanos customizable electronic forms, and achieve higher productivity and efficiency

  • Powerful customization tools and simple templates.
  • No coding is required; simply drag and drop
  • Support a wide variety of field types.
  • Build custom workflows in just a few clicks.
  • Setup traceability between different artifacts
  • Setup form logic such as mandatory rules
  • Complete access control
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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!"

Stuart H

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.


Igor Stankovski

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.


Eli Zehavi

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…


Oren Tamari

CEO, Upnride

…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…



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Why you choose Orcanos



Combine Design Control (ALM) with quality management system and regulation in a central repository

DHF - Document Generator

DHF - Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrated Risk Management

By incorporating risk management into your development process, you can mitigate potential hazards and prevent failure, while adhering to the ISO 14971 guidelines.

21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Orcanos supports electronic records and electronic signatures in compliance with 21 CFR Part 11.

Easy Customization

Easy Customization

Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions

Dashboards And Analytics

Dashboards And Analytics

Gain improved tracking and control through a custom dashboard builder that includes reports and charts. Keep track of project progress and the status of quality procedures, including requirements traceability, test results, risk assessments, CAPA, and other metrics.

End To End Traceability

End To End Traceability

Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability

Realtime Alerts

Realtime Alerts

Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week

Your virtual Auditor

Your virtual Auditor

Use Orcanos Compliance Engine to get a real-time audit of your projects, anywhere, anytime!


Your next electronic audit with Orcanos

Assure your success with the only system that combines your design control with Quality and Regulations

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