Orcanos review

About the price: No public prices (Sep 2026). Listing sites show a vendor-supplied '$99 per feature per month'; older edition prices of $990–1,250 a month appeared only in search snippets and couldn't be verified. Onboarding and validation package listed as included.

What is Orcanos?

Orcanos Ltd. is an Israeli software company based in Givatayim, with a US office in New Jersey.¹ A co-founder is CEO.² LinkedIn lists 11–50 employees.³ The company was incorporated in December 2004, and the vendor says it has built for medical devices since 2005.⁴⁵ It claims more than 100 MedTech customers.⁶

The platform has two halves that share one data model.⁶ ALM covers design control: requirements, risk, testing, defects and DHF compilation. QMS covers document control, CAPA, audits, nonconformances, suppliers and training.⁶ There is no integration to maintain between them, because both live in the same database. Capterra still lists the product under an old name, “ALM 2.0”.⁷

Today both halves come in one plan (Essentials and up), so we review them as a single product.⁸

Who Orcanos is for

The best fit is a device company where engineering and quality want one traceable record. The help center documents risk items linked to mitigating requirements and to verification tests.⁹ It also documents traceability reports that expose missing tests, and flags that mark linked items when something changes.¹⁰¹¹ Software teams get test automation through the API and IEC 62304 compliance checks that take a software safety class.¹²¹³ Hardware makers get engineering change orders, DMR and DHF records and electronic device history records.¹⁴¹⁵¹⁶

Look elsewhere if you need well-documented supplier, audit or nonconformance workflows, or regulatory reporting. We found only marketing pages for the first three and nothing for UDI, eMDR or EU vigilance.¹⁷¹⁸¹⁹

Orcanos pricing

Orcanos doesn’t publish prices. Its pricing page lists three plans, checked 30 September 2026:⁸

• Starter: 3 users, 5 viewers, 3 projects, and either up to four QMS processes or the full ALM module, not both.
• Essentials: 5 users and 10 viewers, full QMS and ALM, single sign-on and the Ask Paul AI assistant, with users added as you grow.
• Professional: adds custom processes, API access, the Service Center module, enhanced support and a sandbox.

All plans list a full validation package, basic onboarding, business-hours chat support and ready-made templates.⁸ Enterprise plans are custom.⁸

Capterra and its sister sites show a vendor-supplied starting price of “$99 per feature per month”, without saying what a feature is.²⁰ Older edition prices of $990 a month for ALM or QMS and $1,250 a month for both appeared in search results for TrustRadius. We couldn’t open that page or an archived copy, so we don’t rely on those numbers. A customer story does mention buying the “PREMIUM” package.²¹ Two Capterra reviewers call it expensive per user.⁷ Without two independent price signals, we show the price as “on request”.

Features

Document control, records and training

Documents move through draft, in-work, approved and obsolete states. Signers can be set in sequence or in parallel, and approved files are published to PDF with a signature cover page.²²²³ SOPs stay as Word or Excel files that you check out and edit in Office. A new Word add-on inserts live revision and approval fields, but it runs on Windows only.²³²⁴ An older FAQ says the document system has no full-text search and imports only the latest revision of legacy files.²³ When a revision is approved, read-and-understand training tasks go automatically to named people or job roles, and trainees sign them.²⁵

Design controls and risk

The FMEA module follows ISO 14971 from hazard to mitigation and verification.⁹ The risk management file is generated to Word.²⁶ The document generator exports design documents such as a software requirements specification to Word, using your own templates and including test results.²⁷

CAPA, complaints and nonconformance

A walkthrough in the help center shows a CAPA e-form where the root cause must be signed before the CAPA can advance, with action items added underneath.²⁸ Complaints come in through the Service Center, which links calls to defects and CAPAs. That module is only on the Professional plan.²⁹⁸ Nonconformance and material review boards are described on marketing pages and in an old blog post, not in the help center.¹⁹³⁰

Suppliers and audits

Supplier qualification, scorecards and audit checklists appear only on marketing pages.¹⁷¹⁸ The documented “Audit Insights” feature is different: it automatically checks project data against rules such as “every requirement has a test”. It doesn’t plan internal audits.¹³

Integrations and API

The REST and SOAP API is publicly documented.³¹ Jira connects through Zapier, following a step-by-step guide.³² GitHub and Azure DevOps are named on the homepage but not documented.⁶

What users say

On G2, Orcanos has 4.3/5 from 125 reviews, with 7.8/10 for ease of use and 8.9/10 for quality of support (September 2026).³³ Capterra shows 4.3/5 from 37 reviews.⁷ On SoftwareReviews, 21 reviews give it a composite 5.9/10, with lower marks for usability than for implementation.³⁴

• Ease of use is a recurring complaint. Recent G2 reviewers say the interface could be more user-friendly, and that the admin side needs deep understanding even if end users find it easy once set up.³³ A SoftwareReviews reviewer calls its e-forms non-intuitive.³⁴ Some Capterra reviewers call it easy to use, while others say it takes training.⁷
• Reporting: a 2025 G2 reviewer says the filter and visualisation tools sometimes don’t fit their needs, so they fall back on exports.³³
• Speed: several Capterra reviewers report slowness, for example in tree views or with many users online.⁷
• Support is mostly praised as fast and responsive.⁷³³
• Stability: some older Capterra reviews (2019–2022) mention bugs and new releases that weren’t tested enough.⁷

We found no first-hand posts about Orcanos on Reddit or quality forums.

All 130 G2 reviews were read in October 2026: 75% are labelled by G2 as invited by the vendor or incentivized, and 29% of them arrived within a single six-week window.³⁵ Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

Security, hosting and validation

Orcanos is certified to ISO 27001:2022 (certificate valid until September 2028) and runs on AWS. Each customer gets its own database and file system.³⁶ Non-US customers use a separate application host from US customers.³⁷ The vendor says it uses hosting providers in Europe and the US, and that data stays in its EU or US zone and isn’t transferred between them.³⁸³⁹ It doesn’t name the country. Its terms refer to a DPA with subprocessors, but we found no public copy or subprocessor list.⁴⁰ Ask for the exact region and the DPA before signing. On-premises licences are also offered.⁴⁰

Release 6.0 shipped in January 2026 as “fully validated”, with a validation pack, but its contents aren’t published.⁴¹ Single sign-on works with SAML 2.0, Office 365, Google and Okta, and can be required for e-signatures.⁴² AI features are off by default, and customer data isn’t used for model training.⁴⁰

Buying and contract terms

• Trial: we found no free trial. The site offers a 30-minute live demo, plus free video courses and help-center tutorials.⁶⁴³ Capterra says there’s no trial; GetApp says there is one.²⁰
• Term: the terms mention “subscription plans of various durations” and auto-renewal unless you cancel at least seven days before.⁴⁰ No minimum term is stated.
• Export and API: document trees export as folders of files, records export to CSV or Excel, and a public API is documented.⁴⁴⁴⁵³¹ The terms add that closing the account deletes all data, with no exit-export clause.⁴⁰
• Price increases: the terms let Orcanos change prices, with increases taking effect at the end of your current billing cycle. There’s no cap.⁴⁰ Because no prices are published, there’s no price history to compare. The plans did shrink: in 2024, Essentials went from 10 included users to 5, Starter from 5 to 3, and API access moved up to Professional.⁴⁶⁴⁷ We don’t know whether prices changed with them. We found no user reports of renewal hikes.
• If the vendor is sold or closes: the terms don’t promise data return or escrow, and closing an account deletes its data.⁴⁰ The privacy policy says a buyer would have to honour its privacy commitments, and that customers would be told of a change in ownership; it doesn’t cover getting your data back.³⁸ Export your records regularly, and ask for an exit clause in the order form.
• Time to go live: the vendor claims 14 days for the QMS, and a 24-day average across customers.⁶

Company and ownership

• Legal entity: Orcanos Ltd., an Israeli private company, number 513619569, registered in Givatayim. The register lists it as active, incorporated on 16 December 2004, with its latest annual report filed for 2025.⁴ It’s also the contracting party in the terms, which are governed by Israeli law.⁴⁰
• Management: a co-founder is CEO, according to the vendor.²
• Ownership: privately held. The public register data doesn’t list shareholders, and we found no announced funding rounds, investors or acquisitions as of October 2026.⁴ In 2024 Orcanos announced a partnership with CYTO Consulting to grow in the US. That’s a sales partnership, not an ownership change.⁴⁸
• Financials: we found no published accounts.

Verdict

Shortlist Orcanos if you want design controls, risk, testing and quality records in one traceable system, especially for software-heavy devices. The engineering side is well documented, and onboarding and validation are included. The main reasons for caution: no public prices, a small vendor, and supplier, audit and nonconformance workflows you’ll need to see in a demo.

Visit the Orcanos website (made by Orcanos Ltd.)