ALM and Quality Management
Founded in 2005, Orcanos Software has built its reputation on delivering integrated solutions that ease the time-to-market product hurdles that are part of the Quality Journey. 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), that includes regulatory compliance, with a specialized focus on the medical device industry.
As a result Orcanos has years of proven experience and innovation in a regulated and increasingly high-tech industry. Our team has honed their skills by working with medical device manufacturers and other high-tech companies, not only assisting them in building their operational excellence capabilities but also ensuring that the product lifecycle proceeds on a smooth path from day one.
Move to Paperless System
Paper-based processes have become chokepoints for many companies, and we have dedicated ourselves to a more streamlined process which shifts 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.
Our vast experience and expertise has given us the ability to provide tailor-made and custom solutions to medical device companies of all sizes. Additionally, the integrated ALM and QMS solution that we offer sets Orcanos apart from other quality management vendors and consultants in what is a highly competitive marketplace.
Life Science Industry Solution
We believe that 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 been able to improve productivity and product quality, streamline compliance with regulations such as ISO 13485, IEC 62304 and ISO 14971, better comply effectively with regulatory authorities such as FDA and CE. And by using Orcanos smart dashboards and real-time alerts, our customers not only keep track of their ongoing projects but also have real-time visibility on a product’s progress along its quality journey.
MEET THE TEAM
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
"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.
"Orcanos gives use Excellent solution"
Linor V - Document Controller
Flexibility, Fit our needs, Fest answer and
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…