--- title: Orcanos Reviews meta_title: 'Orcanos Reviews 2026: Details, Pricing, & Features | G2' meta_description: Filter 125 reviews by the users' company size, role or industry to find out how Orcanos works for a business like yours. aggregate_rating: rating_value: 4.3 review_count: 125 scale: '5' date_modified: '2026-07-17' parent_category: name: Life Sciences url: https://www.g2.com/categories/life-sciences --- # Orcanos Reviews **Vendor:** Orcanos **Category:** [Medical Quality Management Systems (QMS)](https://www.g2.com/categories/medical-qms) **Average Rating:** 4.3/5.0 **Total Reviews:** 125 ## About Orcanos Orcanos is a modern MedTech eQMS platform designed to help regulated teams accelerate compliance, stay audit-ready, and streamline quality processes — from design to post-market. Unlike traditional QMS solutions, Orcanos also includes integrated development lifecycle tools (ALM), enabling full traceability across requirements, risks, testing, and quality in one system — without coding. Key Capabilities Document Control & Training CAPA, NCR, Complaints & Audits Risk Management (ISO 14971) Design Control / DHF / DMR Requirements & Test Management End-to-End Traceability Electronic Signatures & Validation Support (FDA, ISO, EU MDR) Why Orcanos Built for regulated hardware, MedTech & pharma Codeless workflows & fast implementation Unified quality + product development data ## Orcanos Pros & Cons **What users like:** - Users commend Orcanos for their **exceptional customer support** , showcasing readiness to assist and resolve issues effectively. (14 reviews) - Users commend the **ease of use** of Orcanos, highlighting its intuitive interface and excellent support for all skill levels. (14 reviews) - Users value Orcanos for its **comprehensive tools** that enhance traceability and streamline product development processes effectively. (8 reviews) - Users value the **high customization** options of Orcanos, allowing seamless adaptation to their unique processes and needs. (7 reviews) - Users appreciate the **user-friendly document management** of Orcanos, benefiting from its intuitive and flexible interface. (6 reviews) - Users find Orcanos **intuitive and easy to use** , appreciating its seamless integration and excellent customer support. (6 reviews) - Implementation Ease (5 reviews) - Users value the **customizability and integration** of Orcanos QMS, enhancing organization and efficiency in quality management processes. (5 reviews) - Automation (4 reviews) - Customization (4 reviews) **What users dislike:** - Users find **feature limitations** in Orcanos, noting gaps in integrations, slow performance, and a lackluster export process. (6 reviews) - Users note that **slow performance** with loading times and server responses hampers their overall Orcanos experience. (6 reviews) - Users find the **learning curve steep** , complicating the use of Orcanos, especially during implementation and revision management. (5 reviews) - Users find the **difficult usability** of Orcanos challenging, particularly with complex administration and limited user support. (4 reviews) - Users find Orcanos to be **not intuitive** , struggling with its complex UI that obscures essential content and files. (4 reviews) - Document Management (3 reviews) - Inefficient Workflow (3 reviews) - Not User-Friendly (3 reviews) - System Limitations (3 reviews) - Difficulty in Modification (2 reviews) ## Orcanos Reviews ### 1. Orcanos QMS & Design Control **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** June 22, 2021 **What do you like best about Orcanos?** We assesed several systems that would cover not only managing the QMS, but also how we integrate non-office based design control management including requirements, risk management and traceability. There were options for either, but Orcanos gave us the ability to integrate the ALM/Design side and QMS side in one process in a way that others were not able to. We've used Orcanos to build a more integrated design process, which has engaged designers more and move us away from Word/Excel documents and provided the tools for enabling traceability throughout the design process. The available QMS work items has improved our document & change processes and we've used the Zapier integrations to build better workflows for complaint and CAPA management. Transitioning to a paperless system was a core driver for the project and having a system that would grow with us was key, which is reflected in the pricing structure. The fact that Orcanos comes validated as a package has saved time as we've expanded and the support from the whole Orcanos team as made the transition worth the effort. **What do you dislike about Orcanos?** The user interface, when moving from a MACOS, takes some getting used to; however, once you've used it for a while, it becomes more intuitive. Some of the processes took a little longer to transition, but the support from Orcanos enabled us to get those implemented. **Recommendations to others considering Orcanos:** There are many ways to configure Orcanos for your use-case; make sure the project is resourced appropriately to ensure the maximum benefit is realized. **What problems is Orcanos solving and how is that benefiting you?** The core driver for the implementation of Orcanos was moving to a paperless QMS that included 21 CFR part 11 compliant signatures and having a design process that didn't depend on Word/Excel documents and allowed modern methods of working. The use of Orcanos has demonstrated to the design (product/software/hardware) teams that a design control process does not need to involve word documents and excel spreadsheets that are complicated and time-consuming to manage. We're in the early stages of using this within software development, but improving our design process such that features and traceability are managed across Product Management and Software Engineering rather than centralized in a few people has already enhanced the compliance activities within the organization. ### 2. Very good and easy to use the system **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** February 21, 2022 **What do you like best about Orcanos?** the most helpfull for me is the document Management and the Esign process **What do you dislike about Orcanos?** Errors with the same promblem that repeating themselves **What problems is Orcanos solving and how is that benefiting you?** Any problem or I have always resolves quickly ### 3. Easy and user friendly **Rating:** 5.0/5.0 stars **Reviewed by:** Dina G. | QA/RA Manager, Small-Business (50 or fewer emp.) **Reviewed Date:** February 20, 2022 **What do you like best about Orcanos?** Technique support. Easy to find answers to the problems. **What do you dislike about Orcanos?** You can not cancel "start routing" to number of the documets. You have to cancel each document seperatly. **What problems is Orcanos solving and how is that benefiting you?** Save time ### 4. Great documentation system, very useful and easy to work with, recommend for small/big organizations **Rating:** 4.5/5.0 stars **Reviewed by:** Oren Z. | Director of Technical Support, Mid-Market (51-1000 emp.) **Reviewed Date:** January 31, 2022 **What do you like best about Orcanos?** Simplicity with getting the documentation in Orcanos **What do you dislike about Orcanos?** I would try to create it more cullerfull **What problems is Orcanos solving and how is that benefiting you?** I was mange to review and find files I didn't find before, as system is easy to use and user friendly ### 5. Great tool for test management **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** December 21, 2021 **What do you like best about Orcanos?** The tool helps you to manage test runs and cases efficiently. support we get from the Orcanos team members is great. **What do you dislike about Orcanos?** UI/UX can be better as it's very complicated system. Better UI can help your first steps into the system. **What problems is Orcanos solving and how is that benefiting you?** Management of the testing documents, test cases, tests runs. ### 6. Experience with training project and electronic forms - easily used, once established **Rating:** 4.0/5.0 stars **Reviewed by:** Noa C. | Regulatory and Clinical Administrator, Small-Business (50 or fewer emp.) **Reviewed Date:** January 09, 2022 **What do you like best about Orcanos?** all information and all documents in one system **What do you dislike about Orcanos?** missing "global" search - would like to be able to search all over **Recommendations to others considering Orcanos:** check thoroughly to see it meets all expectations **What problems is Orcanos solving and how is that benefiting you?** QMS all in, traceability works well. ### 7. Using Orcanos as product manager **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** February 21, 2022 **What do you like best about Orcanos?** The connection between managing documents in the alm side (PRD) and tracing them to the document control. **What do you dislike about Orcanos?** It's difficult to write comments and track changes in building the PRD. **What problems is Orcanos solving and how is that benefiting you?** We use it to manage multiple projects and trace them as one big unit. Managing the different versions in one platform. ### 8. For early QMS implementation phase, Orcanos provide a very good solution. **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** February 08, 2022 **What do you like best about Orcanos?** Very good traceability solution. Admin has customization capabilities in the framework, not compromising the system's validity. **What do you dislike about Orcanos?** BOM module is very cumbersome. The process of creating the BOM structure is not designed effectively. Customer service (service calls) responsive time may be improved. **What problems is Orcanos solving and how is that benefiting you?** Managing the QMS electronically. Complying to regulatory requirements. User interface is very intuitive and convenient. ### 9. Good idea, but not the most intuitive **Rating:** 3.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** November 16, 2021 **What do you like best about Orcanos?** Hierarchy display of folders for documents. The drag and play **What do you dislike about Orcanos?** System is not flexible. Same numbering format for all document Annoying process to see approved documents **Recommendations to others considering Orcanos:** Good way to store documents , however not the most intuitive system **What problems is Orcanos solving and how is that benefiting you?** We are solving the document control and storage of documents **Official Response from Kfir Peretz:** > Thanks for taking the time to review Orcanos! our system is always improving and getting constant updates, we will take your notes and feedback into consideration. ### 10. Using ORCANOS for Medical Devices **Rating:** 5.0/5.0 stars **Reviewed by:** Gerd E. | Lead System Architect, Mid-Market (51-1000 emp.) **Reviewed Date:** February 03, 2021 **What do you like best about Orcanos?** One database, one tool and user interface for requirement-, risk-, test-, CAPA-management etc. Item based!!! with the possibility to generate documents on each level. No need to manage interfaces , relatively fast to configure for own needs, without writing and validation of user-ware. 100% cloud based and platform independent. Without knowing about Covid as we took the decision, this feature became more important than foreseen. Zero efforts were needed to work from home. Good discussions with ORCANOS about new features or improvements. **What do you dislike about Orcanos?** Data response times are sometimes long as we handle several thousands of items. Generating "nice" MS-Word files with special formated tables and using own templates could be improved. But this is probably a typical MS-Word issue as the html view and output is fine. As we have a very complex system of systems structure (e.g. a CT scanner is just a sub-component), the management of this complex hirachy is by nature a challenge. The number of project hirachies and their management could be improved. **What problems is Orcanos solving and how is that benefiting you?** We were looking for an "all in one" and 100% cloud-based tool (remote work from anywhere) with as low as possible efforts for the tool administration itself, as far as possible self-explaining to optimize training efforts. Further a tool, which covers all the needs for medical devices. This is all covered and we manage thousands of items with Orcanos. Actually, we use it "only" for risk- requirement- and test-management as we already had before a DMS (Document Management System) in place. Best would be to use Orcanos as management tool for the overall product lifecycle, from first ideas (business requirements) to PMS, including as far as possible the 13485 requirements like non-conformities, complaint handling and CAPA management, DMS etc. ### 11. Friendly software. Wide range of possibilities **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** February 22, 2022 **What do you like best about Orcanos?** Enables a complete digitalization of the documents **What do you dislike about Orcanos?** The initial management is time-consuming **What problems is Orcanos solving and how is that benefiting you?** It will automize the whole protocol process when it's finally functioning ### 12. Review of Orcanos **Rating:** 5.0/5.0 stars **Reviewed by:** Stuart H. | Small-Business (50 or fewer emp.) **Reviewed Date:** December 22, 2020 **What do you like best about Orcanos?** I love the flexibility of Orcanos! It feels like the system is almost 100% configurable, so whenever I think 'it would be nice to do this' then I can always do it within the system. The traceability function is awesome too, it means that we can link our items together so that we can get an overview of the project from top to bottom. **What do you dislike about Orcanos?** Not really a dislike, but to begin with I found the 'back end' slightly overwhelming, but I was surprised by how easy it was to use when I got started. I think the menu just looks very full, but everything is in a logical place which really helps if you do not come from a technical background. **What problems is Orcanos solving and how is that benefiting you?** We used to spend huge amounts of time doing many of our QA processes manually. This meant maintaining trackers, and signature logs, and constantly archiving/retiring documents, etc. As our business grew, it was becoming impossible to stay on top of all of this. Since using Orcanos, most of our processes are automated and we have been able to become far more efficient and streamlined. Additionally, our overall compliance is far better than before as there are fewer areas where people can fall through the gaps. ### 13. Helped to increase our business speed by automating many tasks - Provides real-time continuous audit **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Hospital & Health Care | Enterprise (> 1000 emp.) **Reviewed Date:** February 16, 2021 **What do you like best about Orcanos?** I am not in the details as I am the business leader, not the daily user. But I know this: As a test, I proposed stopping our contract with Orcanos and there was nearly a team revolt because they had come to depend on it to reduce time to accomplish tasks. The business leaders at Orcanos are competent and engaged and responsive. **What do you dislike about Orcanos?** There is not a lot to dislike in our setting. **What problems is Orcanos solving and how is that benefiting you?** The key benefit to us is that it helps to reduce the time between software releases. Because the takt time of our releases is therefore reduced, our Product Managers can be more disciplined about content that they specify for each release and our predictability goes up. ***There is no place for comments in this form, so I am inserting a comment here: Though we are happy users of Orcanos, our organization does not permit promotional attribution of other companies' products. I have therefore marked the advertising and name fields below as do-no-disclose.*** ### 14. Flexible **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** November 21, 2021 **What do you like best about Orcanos?** Write and export documents on the same platform **What do you dislike about Orcanos?** Missing some function which would like to have. Add Used items while test running not only SW version if run verification tests on Design and not on SW **What problems is Orcanos solving and how is that benefiting you?** Traceability ### 15. Full document control system **Rating:** 5.0/5.0 stars **Reviewed by:** Jason R. | Small-Business (50 or fewer emp.) **Reviewed Date:** January 07, 2021 **What do you like best about Orcanos?** Orcanos provides a complete document control solution compliant to the latest medical device standards. This includes digital signatures to FDA 21 CFR part 11, full change history, and release control through ECO's. Document can also be created within Orcanos itself allowing individual requirements to be traced from system concept stage through to validation & verification and on to release. **What do you dislike about Orcanos?** Sometimes the exported documents need a bit of tidying up. **What problems is Orcanos solving and how is that benefiting you?** Orcanos is used as both the e-QMS and the document control system for the whole company. This allows us to manage all the regulatory aspects through one system, and it has allowed us to rapidly generate, control and monitor the quality processes for our IOS 13485 certification. ### 16. Senior Design Assurance Engineer **Rating:** 4.5/5.0 stars **Reviewed by:** Hein S. | Mid-Market (51-1000 emp.) **Reviewed Date:** December 16, 2020 **What do you like best about Orcanos?** Orcanos is ideally suited for use in start up environment. In our implementation we combine full ALM and Risk Management on the development side with the full QMS, Training, and soon integration PLM. **What do you dislike about Orcanos?** The high level of flexibility means that we can meet our needs in a simple, straight forward manner. The downside is that each quality process must carefully be crafted to meet our needs. The upside is that we are not forced into cookie-cutter work-flows. **What problems is Orcanos solving and how is that benefiting you?** As a pre-market device company, we need to combine rapid growth with quality systems that allow us to get to market in an efficient manner. Orcanos has already created tremendous value in improving visibility and reducing administrative overhead versus paper-based methods. ### 17. full deployment of all QMS business flows **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Hospital & Health Care | Mid-Market (51-1000 emp.) **Reviewed Date:** December 10, 2020 **What do you like best about Orcanos?** The flexibility we have to design the tool to our needs. The design support we get from Orcanos - speed and quality. The tool configuration and use Bridge to other systems we work with **What do you dislike about Orcanos?** heavy effort on tool validation for medical device integration to BI system to get better monitoring/dashboard and analysis **Recommendations to others considering Orcanos:** Orcanos strength is the modularity - you can use per module or all together, this can give a great solution for projects which has partial solution and need to close the gap or need end2end solutions **What problems is Orcanos solving and how is that benefiting you?** basically we are always ready for audit - tool makes sure we have continuous monitoring to identify our QMS gaps We need to operate in frequent releases, which is challenging in the medical device limitations. Orcanos enabled us the speed we needed to minimize the overhead of each release - all is integrated in the flow ### 18. Orcanos gives use Excellent solution for Document control & ECO Process **Rating:** 5.0/5.0 stars **Reviewed by:** Linor V. | Documentation Control Leader, Mid-Market (51-1000 emp.) **Reviewed Date:** December 22, 2020 **What do you like best about Orcanos?** Flexibility, Fit your needs,Quick and available response **What do you dislike about Orcanos?** sometimes it's slowly.when you try to open big folder **Recommendations to others considering Orcanos:** If you want to build your process and vision, you can use Organos. Orcanno team can support you all the way. They will create and help you to solve and think out of the box and will give your company excellent solutions to improvement in the process. **What problems is Orcanos solving and how is that benefiting you?** For example, we would like to change a work method in the ECO process, and we get positive feedback and fest solution. We start to manage the implementation in Orcanos under the ECO process by building our process with our needs. if we have a new vision, we share it with the Orcanos team, and we are talking and found the best way to create it in Orcanos. ### 19. Orcanos has been very useful in helping us maintain our document control system. **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** May 24, 2021 **What do you like best about Orcanos?** We have been using Orcanos for our electronic Quality Management System. With a company that is quickly growing, the system is quite easy for everyone to view and download documents and manage document changes effectively. The Orcanos support team are always very helpful with navigating the system and provide responses in a timely manner. **What do you dislike about Orcanos?** Sometimes the system can be difficult to navigate, particularly on the backend. **What problems is Orcanos solving and how is that benefiting you?** We have been mainly using the system for document control and are now beginning to implement ECOs and Complaints. ### 20. The optimal ALM system for medical devices **Rating:** 5.0/5.0 stars **Reviewed by:** Almog A. | Small-Business (50 or fewer emp.) **Reviewed Date:** December 21, 2020 **What do you like best about Orcanos?** The integrative approach, Risks, Requirements, Tests, flexible traceability, ECOs all working seamlessly enabling on-demand compliance. The system is extremely flexible which meets our demands. **What do you dislike about Orcanos?** Some aspects of the graphical user interface. **Recommendations to others considering Orcanos:** This is your system if you are looking for a unified ALM and compliance solution for medical devices. **What problems is Orcanos solving and how is that benefiting you?** Risk management, Document management, Requirements management, Product specifications, testing - planning and execution, change management, regulatory submissions, clinical document management, traceability. The system helps keep us in compliance and manages workflows that ensure end-to-end consistency. ### 21. Orcanos review **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Biotechnology | Small-Business (50 or fewer emp.) **Reviewed Date:** January 07, 2021 **What do you like best about Orcanos?** The Orcanos system provides your project needs in the best possible way: Requirement management, traceability, reports, and the ability to get ready for an audit. It is effortless to use once you learn the system, and the customer support is excellent. **What do you dislike about Orcanos?** It is hard to get the hang of it initially, and it took some time to adapt to our needs. **What problems is Orcanos solving and how is that benefiting you?** Develop and implement standards for inspection, Prepare, review, revise, and maintain software design documents, Plan, and perform different stages of testing, Prepare reports by collecting, analyzing, and summarizing data. The system helps keep us in compliance and manages workflows! ### 22. Orcanos is a fully features eQMS that with capabilities that other systems do not have **Rating:** 4.0/5.0 stars **Reviewed by:** Asaf O. | Small-Business (50 or fewer emp.) **Reviewed Date:** December 10, 2020 **What do you like best about Orcanos?** Traceability from requirements via risks to test cases; incorporation of automated DHR **What do you dislike about Orcanos?** GUI could be better, but certainly ok once you get used to it **What problems is Orcanos solving and how is that benefiting you?** Entire DHF in one place, traceable. Digitally signed. All QMS activities, such as training, ECO, calibrations, customer complaints, etc are all controlled and in one place ### 23. The best quality software in the medical industry **Rating:** 5.0/5.0 stars **Reviewed by:** Danit B. | Founder & LinkedIn Coach, Mid-Market (51-1000 emp.) **Reviewed Date:** December 23, 2020 **What do you like best about Orcanos?** The attention to details and the risk and problem alerts **What do you dislike about Orcanos?** The problem indicators. It gives you the tools to fix the problem. **What problems is Orcanos solving and how is that benefiting you?** Digital transformation to our manual medical documents ### 24. My QMS partner **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** December 09, 2020 **What do you like best about Orcanos?** Easy accessibility to the documents. Traceability function Dashboard **What do you dislike about Orcanos?** The inability to arrange documentation into alphabetical order. **What problems is Orcanos solving and how is that benefiting you?** Updating Risk analysis. Revision updating History ### 25. review **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** January 02, 2021 **What do you like best about Orcanos?** The complete workflow and flexibility of the tool **What do you dislike about Orcanos?** Ramping up was slow and tailoring it to our workflow, which is standard, took time **What problems is Orcanos solving and how is that benefiting you?** Document and requirement control ## Orcanos Discussions - [Does an Orcanos user community forum exist and is it possible to share experiences](https://www.g2.com/discussions/does-an-orcanos-user-community-forum-exist-and-is-it-possible-to-share-experiences) - 1 comment, 1 upvote - [View Orcanos pricing details and edition comparison](https://www.g2.com/products/orcanos/reviews?page=3§ion=pricing&secure%5Bexpires_at%5D=2026-08-01+02%3A09%3A12+-0500&secure%5Bsession_id%5D=8cdb4f92-db37-4042-96a3-bba540b2ba8c&secure%5Btoken%5D=06aad1e02a8b1b2170afae33bab9eb854d1dcdead2f565be611473a8de5ea252&format=llm_user) ## Orcanos Integrations - [Oracle Product Lifecycle Management (PLM)](https://www.g2.com/products/oracle-product-lifecycle-management-plm/reviews) ## Orcanos Features **Quality Management** - Design Controls - Audit Management - Supplier Network Management - Risk Management **Nonconformance** - Conformance Records - CAPA - Change Management **Quality System** - Analytics & Reporting - Real-time Collaboration - Document Control - Quality Processes **Quality system** - Document Control - Collaboration - Analytics and Reports **Risk Management** - Assessments - Operational Risk - Supplier Evaluation **Inspection Management** - Templates - Workflows - Corrective Actions **Compliance** - Standards & Regulations - Certifications **Platform** - Integration - Security & Privacy - Mobile Access - Flexibility **Services** - Implementation - Training & Learning - Customer Support - Professional Services ## Top Orcanos Alternatives - [Qualio](https://www.g2.com/products/qualio/reviews) - 4.4/5.0 (771 reviews) - [Greenlight Guru Quality Management System](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews) - 4.5/5.0 (401 reviews) - [Arena PLM & QMS](https://www.g2.com/products/arena-plm-qms/reviews) - 4.2/5.0 (452 reviews)