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SPECIFICTION
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Orcanos

orcanos.com

WebAPI
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Spec score 6.9 #7 of 21 in Application Lifecycle & Release Management

What it is

Orcanos combines quality management and application lifecycle management 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 module handles document control, CAPA and complaints, audits, suppliers, and training. It also lists 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. Integrations include GitHub, Jira, and Azure DevOps. The cloud service uses AWS and lists HTTPS transfer, role-based access, IP restrictions, SAML/SSO, ISO 27001:2022 certification, and scheduled backups. Plans range from Starter limits to Professional API access and custom processes; pricing is on request.

Spec sheet

Product
Orcanos combines QMS and ALM in one platform for medical device R&D and Quality teams.Read 9 Oct 2026 · orcanos.com
API
API access is listed as a Professional plan feature, and Orcanos provides REST and SOAP API documentation in its Help Center.Read 9 Oct 2026 · orcanos.com
Integrations
The company lists GitHub, Jira, and Azure DevOps integrations for its regulated ALM product.Read 9 Oct 2026 · orcanos.com
Compliance
Orcanos describes its platform as supporting ISO 13485, EU MDR, FDA 21 CFR Part 11, and ISO 14971-related workflows.Read 9 Oct 2026 · orcanos.com
Support
All three listed plans include business-hours chat support and basic onboarding; Professional also lists enhanced support.Read 9 Oct 2026 · orcanos.com
Headquarters
Ramat Gan, IsraelRead 23 Sep 2026 · orcanos.com
AI assistant
Ask Paul supports AI-assisted requirement writing, risk gap detection, audit summary generation, regulatory change monitoring, and natural-language traceability queries.Read 9 Oct 2026 · orcanos.com
ALM
The ALM module includes requirements and design controls, ISO 14971 risk management, test management, traceability, and defect tracking linked to the DHF.Read 9 Oct 2026 · orcanos.com
Backups
The security center says daily backups are retained for five weeks and weekly backups for twelve weeks.Read 9 Oct 2026 · orcanos.com
eQMS
The eQMS includes document control, CAPA and complaint management, audit and supplier management, and training management.Read 9 Oct 2026 · orcanos.com
Hosting and controls
Orcanos Cloud uses AWS and lists HTTPS data transfer, role-based access control, IP restrictions, and SAML/SSO support.Read 9 Oct 2026 · orcanos.com
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.Read 9 Oct 2026 · orcanos.com
Security certification
Orcanos states that it is ISO 27001:2022 certified.Read 9 Oct 2026 · orcanos.com
Target users
The company presents Orcanos for medical device companies and identifies Quality, R&D, and Regulatory Affairs roles as audiences.Read 9 Oct 2026 · orcanos.com

Plans and prices

Essentials Priced on request 5 users · 10 viewers · Unlimited projects · Full QMS + ALM modules · 40 GB storage Read 9 Oct 2026 · orcanos.com
Professional Priced on request 5 users · 10 viewers · Unlimited projects · API access · Build your own processes · 100 GB storage Read 9 Oct 2026 · orcanos.com
Starter Priced on request 3 users · 5 viewers · 3 projects · Up to 4 QMS processes or full ALM module · 10 GB storage Read 9 Oct 2026 · orcanos.com

Every Orcanos plan and price →

Strong points and limits

Strong points

  • Combines QMS and ALM in one platform
  • Supports medical-device regulatory workflows
  • Includes document, audit, CAPA, and complaint management
  • Offers GitHub, Jira, and Azure DevOps integrations
  • Lists ISO 27001:2022 certification

Limits

  • No free plan is listed
  • Pricing is available only on request
  • Starter limits users, projects, and storage
  • API access is listed only for Professional

Who it suits

It suits medical device companies and Quality, R&D, and Regulatory Affairs teams managing regulated development and quality processes. Web and API access support cloud deployment, with API access listed on Professional.

Verdict

Orcanos brings regulated product development and quality management into one cloud platform, with broad compliance workflows and integrations. Plan limits and on-request pricing should be clarified before selection.

Where Specifiction places it

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