--- title: Aligned Element Reviews meta\_title: 'Aligned Element Reviews 2026: Details, Pricing, & Features | G2' meta\_description: Filter 12 reviews by the users' company size, role or industry to find out how Aligned Element works for a business like yours. aggregate\_rating: rating\_value: 4.5 review\_count: 12 scale: '5' date\_modified: '2026-08-07' parent\_category: name: Life Sciences url: https://www.g2.com/categories/life-sciences --- # Aligned Element Reviews & Product Details Claimed ###### Profile Status This profile is currently managed by Aligned Element but has limited features. Are you part of the Aligned Element team? [Upgrade your plan](https://my.g2.com/aligned-element/upgrade?utm_campaign=s3&utm_medium=claim-popup&utm_source=g2) to enhance your branding and engage with visitors to your profile! The Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle. Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections. Built in traceability matrices, impact analysis, and real time status views make it easy to demonstrate compliance and design control maturity to auditors and notified bodies. Quality events such as CAPAs, nonconformances, complaints, and changes are seamlessly connected to suppliers, equipment, audits and documents. The software can be deployed both as Saas, secure cloud solution or as an on premise installation, allowing companies to choose the deployment model that best fits their IT, data protection, and regulatory strategy. This flexibility makes Aligned Elements uniquely suitable for startups, scale ups, and established manufacturers alike. * * * Seller [Aligned AG](https://www.g2.com/sellers/aligned-ag) Discussions [Aligned Element Community](https://www.g2.com/products/aligned-element/discuss) Languages Supported English Overview by Anders Emmerich Show More ## Pricing Pricing provided by Aligned Element. ### Floating Licenses €2,400.00 1 License count Per Year ### Node-locked License €1,300.00 1 User Per Year [ View More Pricing Information ](https://www.g2.com/products/aligned-element/pricing) ## Top-Rated Alternatives [ ![Altium Develop](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Altium Develop") Altium Develop 4.5/5(1,050) ](https://www.g2.com/products/altium-develop/reviews) [ ![Qualio](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Qualio") Qualio 4.4/5(781) ](https://www.g2.com/products/qualio/reviews) [ ![Octave Reliance (ETQ Reliance)](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Octave Reliance (ETQ Reliance)") Octave Reliance (ETQ Reliance) 4.3/5(624) ](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) [ View All Alternatives ](https://www.g2.com/products/aligned-element/competitors/alternatives) ## User Insights Average based on 12 real user reviews. Typical contract price $0k - $0k [Sign in to view](/login) Per Year [Log in to unlock pricing and user insights](/login) ## Aligned Element Integrations (1) What do users say about integrations? Integration information sourced from real user reviews. [ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") Jira ](https://www.g2.com/products/jira/reviews) Show More ![Sam A.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Sam A.") SA Sam A. Senior Quality Engineer - Team Lead Mid-Market (51-1000 emp.) 8/26/2025 "A fantastic tool for managing design requirements, verification and validation activities, and more" 4.5/5 What do you like best about Aligned Element? Aligned Elements enables the team to easily create, edit, modify and review design requirements in a single place, whilst providing a detailed and complete audit trail for all activities performed on the platform. It allows you to organise the requirements largely as you see fit, with the ability to create folder structures to nest requirements into systems and sub-systems. Having the ability to also perform HAZOP or FMEA on the platform is really useful as you can then provide a direct feedback loop into the requirements when you have mitigated risks. Aligned Elements provide ways to integrate existing systems, such as JIRA integration, which is useful for creating tasks from requirements than can then be fed directly into a JIRA board. The support provided by the team at Aligned Elements is also top notch, with responses to enquiries usually happening on the same day, or within an hour or so. the Aligned Elements team are always grateful for any feedback too. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? Often fitting all of the necessary information that is within a document object into the various screen sizes that are in use can be challenging. In our care this usually relates to verification testing, where we like to input a lot of information into the test, however I will say that Aligned Elements have gone some way into correcting these sorts of problems with a number of updates to the platform, enabling users to scale areas of the page independently. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Organising all of our requirements into a single space, whilst providing an auditable trail of activities. This provides a wide benefit to the whole team involved in the design, development and manufacture of our product, and acts as a single source of truth. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ![Malena C.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Malena C.") MC Malena C. Quality Engineer Small-Business (50 or fewer emp.) 6/5/2025 "Aligned Elements: A powerful tool for ensuring quality and good procedures" 5/5 What do you like best about Aligned Element? Aligned Elements stands out for its intuitive interface, making it easy to navigate even complex documentation structures. The ability to access and organize information in the most useful way—whether through customized queries, trace tables, or filters—greatly enhances productivity. One of the most valuable features is the automatic inconsistency detection, which ensures no critical element or linkage is overlooked, supporting thorough and compliant documentation. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? One area that could use improvement is the training module. As it's still quite new, it lacks the depth and polish found in the rest of the tool. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Aligned Elements helps us maintain strong design control and quality practices by providing structured traceability and enforcing process discipline. It simplifies the generation of documentation directly from objects, which saves time and ensures consistency. The traceability features—linking requirements, risks, and tests—are especially valuable for compliance and audits. This has significantly improved the quality and clarity of our deliverables while reducing manual effort and oversight risks. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ![Louis S.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Louis S.") LS Louis S. QARA Engineer Mid-Market (51-1000 emp.) 6/19/2025 "Handy tool, easy traceability, great customer service!" 5/5 What do you like best about Aligned Element? Easy and compliant way for us to handle traceability, when designing a medical device. Allan our rep provides us with quick and effective support to make sure we know how to use the system and get the most out of it. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? Currently no downsides! We are early in our journey, but so far every problem we have faced, there has been a solution for. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Traceability for medical devices. This is all now automated, instead of using excel! Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ![Verified User in Hospital & Health Care](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Hospital & Health Care") UH Verified User in Hospital & Health Care Mid-Market (51-1000 emp.) 6/17/2025 "Makes regulatory reporting easier with well-organized data" 5/5 What do you like best about Aligned Element? Aligned Element offers a well-structured way to manage traceability and documentation, which is extremely helpful when building compliant and audit-ready reports. The structured templates and clear field mapping make it easier to extract data for Power BI reporting. I also like how it supports change tracking and version control — this is especially useful for maintaining data integrity across updates. The interface is intuitive once you get familiar with it, and the documentation is quite helpful for navigating key features. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? There’s a bit of a learning curve at first, especially when working with integrations or setting up exports for reporting. Some datasets require manual formatting or cleanup before they can be effectively used in Power BI. While the documentation is helpful, a few more tutorials or integration examples (especially for BI/reporting tools) would make it easier to onboard new users. That said, it’s a solid tool once you’re up and running. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Aligned Element helps organize and centralize complex documentation, especially for regulatory and compliance workflows. It solves the challenge of scattered or inconsistent data by providing a structured format for requirements, tests, risks, and traceability. For me as a Power BI developer, this structure makes it much easier to extract, transform, and visualize data. It reduces manual effort and ensures that the data used in reports is audit-ready, up-to-date, and aligned with regulatory expectations. Review collected by and hosted on G2.com. Show More Validated ReviewerSource: Organic ![Angie L.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Angie L.") AL Angie L. Project Engineer Mid-Market (51-1000 emp.) 6/4/2025 "Director of Engineering Operations & Program Management" 5/5 What do you like best about Aligned Element? Trace tables to create Input/Output matrices. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? Formatting capabilities, particularly in test plans. I would like better numbering capabilities. The Windows version is better, but both still seem to have issues with doing any multilevel numbering. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Traceability of inputs and outputs for Design History File documentation. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ST st t. Process Co-ordinator Mid-Market (51-1000 emp.) 6/10/2025 "Creating trace reports and risk assessment documents" 4.5/5 What do you like best about Aligned Element? Tracking traces, flexibility and designing custom-made work items, quick support Review collected by and hosted on G2.com. What do you dislike about Aligned Element? navigation in web edition is not as intuitive as the win edition, creation of word documents can be cumbersome Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Creation of trace reports especially among multitude of linked projects. Review collected by and hosted on G2.com. Show More Validated ReviewerSource: Organic ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") UM Verified User in Medical Devices Small-Business (50 or fewer emp.) 6/16/2025 "Assistance with Import/Export of Requirements" 4.5/5 What do you like best about Aligned Element? Logical workflow, aligns well with my needs. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? Have not used AE long enough to have an opinion on this. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Managing multiple levels of requirements within a class 3 medical device system. Review collected by and hosted on G2.com. Show More Validated ReviewerSource: Organic ## Pricing Options Pricing provided by Aligned Element. ### Floating Licenses €2,400.00 1 License count Per Year ### Node-locked License €1,300.00 1 User Per Year ### Reviewer license €750.00 1 License count Per Year [ View More Pricing Information ](https://www.g2.com/products/aligned-element/pricing) ##### ##### Aligned Element Features Quality Management Design Controls [ View More Features ](https://www.g2.com/products/aligned-element/features) ##### Categories on G2 [Medical QMS](https://www.g2.com/categories/medical-qms)[Requirements Management](https://www.g2.com/categories/requirements-management)[ALM Software](https://www.g2.com/categories/alm-software) ##### Explore More [Which unified insurance suites enable modular configuration without extensive custom development for teams looking to modernise?](https://www.g2.com/discussions/which-unified-insurance-suites-enable-modular-configuration-without-extensive-custom-development-for-teams-looking-to-modernise)[Which community association management systems offer integrated document management and digital record storage?](https://www.g2.com/discussions/which-community-association-management-systems-offer-integrated-document-management-and-digital-record-storage)[Top rated call center tools for tech startups](https://www.g2.com/discussions/what-are-the-top-rated-call-center-tools-for-tech-startups) [Which meeting room booking system offers the most intuitive interface?](https://www.g2.com/discussions/which-meeting-room-booking-system-offers-the-most-intuitive-interface)[What platform integrates work management with collaboration tools?](https://www.g2.com/discussions/what-platform-integrates-work-management-with-collaboration-tools)[Pros and Cons Details](https://www.g2.com/products/aligned-element/reviews?qs=pros-and-cons) [Show MoreShow Less](javascript:void(0);)