Orcanos Israel
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.
Company details
Find locations served, office locations
- Business Type:
- Software vendor
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
- Year Founded:
- 2005
Why you choose Orcanos
ALM+QMS
Combine Design Control (ALM) with quality management system and regulation in a central repository
Document Generator
Easily generate ready for submission documents from your database
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
Define electronic signature process for a complete documents approval lifecycle
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
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
Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability
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Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents.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
Use Orcanos Compliance Engine to get a real-time audit of your projects, anywhere, anytime!
About Us
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.
Tailor-Made Solution
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.