Orcanos
Ramat Gan, Israel
What it is
Orcanos combines quality management and application lifecycle management in a cloud platform for medical device R&D and Quality teams. Its ALM tools cover requirements and design controls, ISO 14971 risk management, testing, traceability and defect tracking linked to the design history file. The eQMS side includes document control, CAPA, complaints, audits, suppliers and training, along with approval workflows, nonconformance tracking and compliance records. Ask Paul provides AI-assisted requirement writing, risk-gap detection, audit summaries, regulatory-change monitoring and natural-language traceability queries. Orcanos describes workflows supporting ISO 13485, EU MDR, FDA 21 CFR Part 11 and ISO 14971. The service runs on AWS and lists HTTPS transfer, role-based access, IP restrictions, SAML/SSO and ISO 27001:2022 certification. Plans have user, viewer, project and storage limits; Professional adds API access. Pricing is on request, and all plans include business-hours chat support and basic onboarding.
For and against
For
- Combines QMS and ALM
- Supports medical-device compliance workflows
- AI assistant covers requirements and audits
- Lists GitHub, Jira and Azure DevOps integrations
- Professional plan includes API access
Against
- Pricing is available on request
- Starter limits users, projects and storage
- API access is listed only for Professional
- Cloud deployment requires web access
The verdict
Orcanos brings regulated product development and quality processes into one cloud system. Its plan limits and on-request pricing are key details to resolve before selection.
Who it suits
It is aimed at medical device companies and teams in Quality, R&D and Regulatory Affairs. It suits organizations needing connected quality and lifecycle workflows in a cloud deployment.
Plans and prices
Essentials
5 users · 10 viewers · Unlimited projects · Full QMS + ALM modules
Read 9 Oct 2026 · orcanos.com
Professional
5 users · 10 viewers · Unlimited projects · API access
Read 9 Oct 2026 · orcanos.com
Starter
3 users · 5 viewers · 3 projects · Up to 4 QMS processes or full ALM module
Read 9 Oct 2026 · orcanos.com
On the record
- AI assistant
- Ask Paul supports AI-assisted requirement writing, risk gap detection, audit summary generation, regulatory change monitoring, and natural-language traceability queries.orcanos.com · read 9 Oct 2026
- ALM
- The ALM module includes requirements and design controls, ISO 14971 risk management, test management, traceability, and defect tracking linked to the DHF.orcanos.com · read 9 Oct 2026
- API
- API access is listed as a Professional plan feature, and Orcanos provides REST and SOAP API documentation in its Help Center.orcanos.com · read 9 Oct 2026
- Backups
- The security center says daily backups are retained for five weeks and weekly backups for twelve weeks.orcanos.com · read 9 Oct 2026
- Compliance
- Orcanos describes its platform as supporting ISO 13485, EU MDR, FDA 21 CFR Part 11, and ISO 14971-related workflows.orcanos.com · read 9 Oct 2026
- eQMS
- The eQMS includes document control, CAPA and complaint management, audit and supplier management, and training management.orcanos.com · read 9 Oct 2026
- Hosting and controls
- Orcanos Cloud uses AWS and lists HTTPS data transfer, role-based access control, IP restrictions, and SAML/SSO support.orcanos.com · read 9 Oct 2026
- Integrations
- The company lists GitHub, Jira, and Azure DevOps integrations for its regulated ALM product.orcanos.com · read 9 Oct 2026
- Plan limits
- Starter lists 3 users, 5 viewers, 3 projects, and 10 GB storage; the higher tiers list 5 users and 10 viewers, with unlimited projects.orcanos.com · read 9 Oct 2026
- Product
- Orcanos combines QMS and ALM in one platform for medical device R&D and Quality teams.orcanos.com · read 9 Oct 2026
- Security certification
- Orcanos states that it is ISO 27001:2022 certified.orcanos.com · read 9 Oct 2026
- Support
- All three listed plans include business-hours chat support and basic onboarding; Professional also lists enhanced support.orcanos.com · read 9 Oct 2026
- Target users
- The company presents Orcanos for medical device companies and identifies Quality, R&D, and Regulatory Affairs roles as audiences.orcanos.com · read 9 Oct 2026
