Secured, Robust and Simple ALM Platform

Requirements Management Tool

Orcanos ALM Requirements tool allows you to plan, approve, trace and validate industry requirements, manage audits and ensure regulatory compliance, all within a seamless integration into a Microsoft Office environment.

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Integrated Risk Management

Integrate risk into your development, and to your QMS, to assure full traceability, and save 30% of the resources spent on manual management.
Ensures hazards are mitigated and prevents failure from happening Generate Risk Management File in just one-click ISO 14971 Compliance

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Test Management Software

Effective testing is a critical part of the quality journey. Orcanos Testing Suite delivers everything that is needed for the verification and validation processes, all operating within a central ALM location. Orcanos Test Management tool enables companies to effectively track and monitor test results, generating these insights in digital formats such as Word, PDF and Excel.

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Defect Tracking

Orcanos Defect Tracking system ensures that all project participants and stakeholders can submit, query, update and report defects easily, while delivering transparent traceability on product features and test cases.

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We Have Your Back

Orcanos makes sure that no document is overlooked, no compliance or other due dates are missed and no preventable events occur. In fact, our system will alert end users and stakeholders every time a potential deviation from stated business goals is detected.


Orcanos ALM meets all the requirements of the FDA medical device compliance protocols for electronic records and electronic signature.

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Orcancos ALM system provides a single data repository for research and development, quality management, and compliance regulations.

Single Repository for R&D Quality And Regulations

Orcancos ALM system provides a single data repository that combines research and development, quality management and compliance regulations. This means that companies can manage all required elements – testing, risk management, CAPA, change management et al - in one place.

End-To-End Traceability

System includes a simple and powerful tool – Traceability Matrix Management – that allows interaction between any ALM or QMS artifact during the process. This includes but is not limited to project requirements, test cases, FMEA risk items, CAPA and customer complaints.

Document Generation

Product database can be shown in a variety of custom templates, all of which can include tables, visual images and embedded dynamic data sets.

Impact Analysis

Orcanos will issue notifications to end users when any change impact is detected via our filters and alerts mechanism.

Just Start Working ...

The system is powerful, complete and provides the support that medical device companies, but its complexity is balanced by how simple the solution is to apply, connect and run.

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…


G2 Recognized Orcanos

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Why you choose Orcanos



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

Document Generator

Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrated Risk Management

Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971

21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Define electronic signature process for a complete documents approval lifecycle

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

Better tracking and control with custom reports and charts builder, to track projects progress and quality procedures status, such as requirements traceability, test run results, risk assessment, CAPA and more

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!


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