Tool profile
Orcanos: cost, fit and limits
Orcanos is a quality and application lifecycle management platform made by Orcanos Ltd. that combines requirements, ISO 14971 risk management, document control and defect tracking for medical device and other regulated manufacturers. Customers pick tiers defined by user and storage limits, with Enterprise quoted separately.
What to know first
Orcanos defines its tiers by limits instead of prices. Starter allows 3 users and 10 GB, Essentials 5 users and 40 GB, Professional 5 users and 100 GB, and Enterprise is a custom quote. Ask Paul, the AI assistant, appears from Essentials upward, while API access waits for Professional. Only a free demo is named as an offer, and no free plan or trial is stated.
Orcanos at a glance
| Maker | Orcanos Ltd., Israel |
|---|---|
| Free plan | No |
| Entry price | Quote only |
| API access | Yes |
| Category | Best AI Requirements Management Software in 2026, rank 6 of 10 |
| Website | orcanos.com |
Who Orcanos is best for
Medical device quality teams
Requirements, hazards and mitigations link in one environment with ISO 14971 risk management, and 21 CFR Part 11 signatures cover document control and CAPA workflows.
Teams compiling a design history file
Defect tracking links to the Design History File, which can be compiled on demand, so audit preparation does not start with a manual collection exercise.
Small regulated teams on a fixed seat count
Plan limits are printed, so a five-person team can see storage and viewer caps in advance, even though the amounts must be requested.
Orcanos plans and pricing
| Plan | Price | What it includes |
|---|---|---|
| Starter | Not published | 3 users, 5 viewers, 3 projects and 10 GB storage; up to 4 QMS processes or the full ALM module, with Document Control and Risk Management. |
| Essentials | Not published | 5 users, 10 viewers, unlimited projects and 40 GB storage; full QMS and ALM modules, Single Sign On and the Ask Paul AI assistant. |
| Professional | Not published | 5 users, 10 viewers, unlimited projects and 100 GB storage; adds a custom process builder, API access, Service Center module and a sandbox account. |
| Enterprise | Custom quote | Named on the pricing page with no details, limits or price shown. Custom quote is the only commercial term shown, so expect to negotiate limits and price directly. |
Checked November 2026.
What Orcanos does
- Ask Paul AI assistant
- Helps write requirements, detects gaps in risk coverage, generates audit summaries, monitors regulatory changes and answers natural-language traceability questions; it appears on Essentials and Professional.
- Cross-artifact traceability
- Links any artifact type to any other, for example a requirement to a hazard to a mitigation, so a quality manager can follow a risk end to end.
- Automatic risk reassessment
- Re-assesses risk when designs change, which reduces the chance that a late design edit leaves the hazard file out of date. Teams keep the hazard file current without asking someone to review each design edit.
- 21 CFR Part 11 signatures
- Electronic signatures work in document control and CAPA workflows, giving regulated teams an auditable approval step without a separate signing tool. Regulated teams get an auditable approval step inside the same system as the records.
- No-code workflow builder
- Role-based access per artifact and team, plus a workflow builder that Professional extends to building your own process. Professional extends the builder so a company can model its own process instead of using templates.
How Orcanos handles your data
The privacy policy says data hosting providers are located in the United States and Europe. It does not state whether customer content is used to train a model, so the vendor's policy was not checked for that. Retention is described for account and billing records only, with billing records kept for 7 years, and no period is given for project data. The company claims no certificate of its own. The platform is described as supporting ISO 13485, EU MDR, 21 CFR Part 11, ISO 14971 and IEC 62304, and a customer testimonial reports a CE mark and FDA clearance.
Where Orcanos falls short in practice
- Small user caps. Starter allows 3 users and Essentials and Professional 5, with viewers capped at 10, so growing teams reach Enterprise or negotiate sooner than expected. Growing teams reach Enterprise or negotiate sooner than they would on a plan with open seats.
- API sits in the top public tier. Programmatic access is only part of Professional, so teams that want to push results from a pipeline cannot do it on Starter or Essentials. Pipelines that push results automatically therefore need the higher plan.
- Evaluation is by demo. The homepage offers a free demo and states no free plan or trial, so hands-on testing depends on what sales agrees to set up. Buyers cannot test the tool alone unless sales agrees to set up access.
Works with
Alternatives to Orcanos
Orcanos: common questions
What are the Orcanos plan limits?
Starter allows 3 users, 5 viewers, 3 projects and 10 GB. Essentials allows 5 users, 10 viewers, unlimited projects and 40 GB. Professional allows 5 users, 10 viewers, unlimited projects and 100 GB. Enterprise is a custom quote. No tier shows a price on the page.
Which Orcanos plan includes the AI assistant?
The pricing page lists Ask Paul on Essentials, and Professional builds on Essentials, so it is included there as well. Starter does not list it. Ask Paul helps write requirements, detects gaps in risk coverage, generates audit summaries and answers traceability queries in natural language.
Does Orcanos support FDA electronic signatures?
The product describes 21 CFR Part 11 electronic signatures in document control and CAPA workflows. It also lists support for ISO 13485, EU MDR, ISO 14971 and IEC 62304. These describe what the platform helps customers meet, and the company claims no certificate for itself on the pages read.
Can Orcanos be reached through an API?
API access is part of the Professional tier and is not listed for Starter or Essentials. The Professional tier also adds a custom process builder, a Service Center module and a sandbox account. Enterprise details were not shown, so confirm API limits with the vendor.
Where does Orcanos host customer data?
The privacy policy says its data hosting providers are in the United States and Europe, without naming which region applies to a given customer. Ask whether you can choose a European region, and ask separately about AI training use, which the policy does not address.