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Orcanos

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What Orcanos is

Orcanos combines quality management and application lifecycle management in one cloud platform for medical device companies. Its ALM module covers requirements and design controls, ISO 14971 risk management, test management, traceability, and defect tracking linked to the design history file. The eQMS module handles document control, corrective and preventive actions, complaints, audits, suppliers, and training. Approval workflows, nonconformance tracking, and compliance records are also listed. Ask Paul offers 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 regulated ALM product lists GitHub, Jira, and Azure DevOps integrations. Orcanos Cloud uses AWS and lists HTTPS data transfer, role-based access, IP restrictions, and SAML/SSO; the company states it is ISO 27001:2022 certified. Plans include business-hours chat support and basic onboarding. Pricing is on request, and plan limits vary from 3 to 5 users, 5 to 10 viewers, 3 to unlimited projects, and 10 to 100 GB of storage.

Who it suits

Orcanos is presented for medical device companies and their Quality, R&D, and Regulatory Affairs teams. It suits organizations seeking QMS and ALM workflows together.

What it does well

  • Combines QMS and ALM
  • Includes document, audit, supplier, and training management
  • Supports traceability and defect tracking
  • Lists GitHub, Jira, and Azure DevOps integrations
  • ISO 27001:2022 certified, according to the company

What to know first

  • Pricing is on request
  • Starter is limited to 3 users and 3 projects
  • API access is listed for Professional

Limits

Starter includes 3 users, 5 viewers, 3 projects, and 10 GB of storage, with up to 4 QMS processes or the full ALM module. Essentials and Professional list 5 users, 10 viewers, and unlimited projects; their storage allowances are 40 GB and 100 GB respectively.

Plans

PlanBilled and limitsPrice
Starter3 users · 5 viewers · 3 projects · Up to 4 QMS processes or full ALM module · 10 GB storageOn request
Essentials5 users · 10 viewers · Unlimited projects · Full QMS + ALM modules · 40 GB storageOn request
Professional5 users · 10 viewers · Unlimited projects · API access · Build your own processes · 100 GB storageOn request

As orcanos.com lists them, read 9 Oct 2026. The maker's own page has the final word.

Getting started

  1. Visit the Orcanos website.
  2. Request pricing for a plan.
  3. Choose a plan based on its listed users, projects, storage, and modules.
  4. Use the web platform in Orcanos Cloud.
  5. Use the included business-hours chat support and basic onboarding.

Verdict

Orcanos brings quality and development lifecycle processes together, with plan limits that differ by tier. Buyers should review the user, project, and storage allowances and request pricing.

Questions

Does Orcanos have a free plan?

No. Orcanos is listed as a paid product.

How much does Orcanos cost?

Pricing is available on request.

Which platform does Orcanos support?

Orcanos is listed for web and API access. Deployment is cloud.

What do Orcanos plans include?

Starter includes up to 4 QMS processes or the full ALM module. Essentials includes full QMS and ALM modules; Professional adds API access and the ability to build custom processes.

Which integrations are listed for Orcanos?

Its regulated ALM product lists GitHub, Jira, and Azure DevOps integrations.

What security certification does Orcanos state it has?

Orcanos states that it is ISO 27001:2022 certified.

Facts from Orcanos's own pages

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, 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, 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, 9 Oct 2026
Backups
The security center says daily backups are retained for five weeks and weekly backups for twelve weeks. · orcanos.com, 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, 9 Oct 2026
eQMS
The eQMS includes document control, CAPA and complaint management, audit and supplier management, and training management. · orcanos.com, 9 Oct 2026
Headquarters
Ramat Gan, Israel · orcanos.com, 23 Sept 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, 9 Oct 2026
Integrations
The company lists GitHub, Jira, and Azure DevOps integrations for its regulated ALM product. · orcanos.com, 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, 9 Oct 2026
Product
Orcanos combines QMS and ALM in one platform for medical device R&D and Quality teams. · orcanos.com, 9 Oct 2026
Security certification
Orcanos states that it is ISO 27001:2022 certified. · orcanos.com, 9 Oct 2026
Support
All three listed plans include business-hours chat support and basic onboarding; Professional also lists enhanced support. · orcanos.com, 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, 9 Oct 2026

Where Orcanos stands on Freedom251

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