About Orcanos

Better Compliance with ALM and Quality Management

Launching Orcanos compliance SaaS in 2017, Orcanos Software has built its reputation on delivering integrated solutions that accelerate the time-to-market for companies that develop products that require regulatory compliance. 

In fact, Orcanos is the only vendor that provides an integrated software solution for Application Lifecycle Management (ALM, aka Design Control) and Quality Management Systems (QMS), which includes regulatory compliance, with a specialized focus on the medical device industry.


Move to Paperless System

Paper-based systems have become bottlenecks for many companies, and we have dedicated ourselves to building software solutions that allow a more streamlined process. Orcanos reduces 80 percent of the manually generated paperwork into a process automation tool. By doing this, we can help our customers implement their business optimization processes and methodologies.

Tailor-Made Solution

Our vast experience and expertise have allowed us to provide tailor-made and custom solutions to medical device companies of all sizes without the need to validate the software for every configuration change. Our flexible integrated ALM and QMS solution also sets Orcanos apart from other quality management and ALM vendors.


Mastering The Life Science Industry

Our solution is a perfect fit for the Life Science industry, especially medical device manufacturers of all sizes, and our customer base ranges from global brands to SMBs. Successful products rely on quality to achieve their goals, an aspirational goal that dovetails with our desire to make the journey as painless as possible.

Medical Device Compliance

To date, Orcanos’ medical device customers have improved productivity and product quality, streamlined compliance with regulations such as ISO 13485, IEC 62304, and ISO 14971, and better comply effectively with regulatory authorities such as FDA and CE.

By using Orcanos intelligent dashboards and real-time alerts, our customers keep track of their ongoing projects and have real-time visibility on a product’s progress along its quality journey.


Your next electronic audit with Orcanos

Assure your success……

Schedule Demo



Zohar Peretz
Rami Azulay
VP Sales & Marketing

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…