Orcanos
Ramat Gan platform that puts an eQMS and a regulated application lifecycle tool on one data model for medical device teams
Quick Overview
| Company | Orcanos Ltd. |
|---|---|
| Category | Quality Management Software (QMS) |
| Headquarters | Ramat Gan, Israel |
| Founded | Not stated |
| EU Presence | Yes - Israel (counted as European) |
| Data Location | Not stated on the pages checked |
| Open Source | No |
| GDPR Compliant | Yes |
| Self-Hosting | Not stated |
| Main Features | Document control with 21 CFR Part 11 signatures, CAPA, complaints, audits, supplier and training management, requirements and design controls, ISO 14971 risk, test management, Jira and GitHub integrations |
| Pricing | Pricing on request |
| Best For | Medical device companies whose software developers and quality staff work in separate tools |
| Replaces | MasterControl, Jira plus separate QMS |
Detailed Review
The privacy policy names Orcanos Ltd. as database owner under Israeli privacy law, with offices at 4 Ariel Sharon Street in Ramat Gan, Israel. Israel counts as European for this directory.
Its pitch is one data layer for quality and engineering, so that a design change triggers a quality impact assessment without a second tool.
Quality and engineering on one model
The platform has three modules: regulated ALM for requirements, risk, tests and defects, a next-generation eQMS, and an AI assistant called Ask Paul. The vendor says every design change is assessed for quality and compliance impact automatically.
The eQMS side
Document control with 21 CFR Part 11 signatures, CAPA and complaint management, audits, supplier management and training with automatic assignments make up the eQMS. The vendor quotes go-live in 14 days with templates and an average of 24 days across customers.
Developer tool links
GitHub, Jira and Azure DevOps integrations are listed, so ticket data from a software team can feed the design history file.
Limitations to Consider
The site copyright still reads 2023 on the terms page and the terms of use are dated May 2019, which suggests legal pages are not refreshed often. Prices and hosting location are not published, and the focus is medical devices, so food or automotive manufacturers should look at CAQ AG. The go-live figures are vendor claims.
Who Should Use Orcanos
Medical device and SaMD companies in Israel and Europe that want requirements, tests and quality records tied together.
Pros and Cons
Pros
- Quality and engineering share one data layer
- ISO 14971 risk coverage
- Integrations with Jira, GitHub and Azure DevOps
- Document control with 21 CFR Part 11 signatures
- Israeli entity with a named Ramat Gan office
Cons
- No published prices
- Hosting location not stated
- Medical device focus only
- Legal pages look dated
Alternatives to Orcanos
Other European quality management software (qms) worth comparing before you decide:
Qualio
Ireland · Cloud eQMS for medtech and biotech with AI gap analysis
SimplerQMS
Denmark · Pre-validated eQMS from Copenhagen with a listed starter price
Scilife
Belgium · Brussels eQMS for pharma and medical devices with module tiers
OpenRegulatory (Formwork)
Germany · Low-cost eQMS and technical documentation for medical device startups
See all European quality management software (qms) or compare them directly against MasterControl on our alternatives page.
Frequently Asked Questions
Yes. The privacy policy names Orcanos Ltd. as database owner under Israeli law, with offices in Ramat Gan.
The ALM handles requirements, risk, tests and defects, while the eQMS handles documents, CAPA, audits, suppliers and training. They share one data model.
The site lists GitHub, Jira and Azure DevOps integrations.