--- 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 MB Manuel B. Senior IT Business Consultant Enterprise (\> 1000 emp.) 7/11/2025 "Innovative Requirements Management System" 4/5 What do you like best about Aligned Element? From the perspective of an IT admin for that system it's perfectly customizable. You can change the process templates, mails sent by the system, create new assistants i.e. for automatic document creation. It's important to mention that the customer support is really outstanding and has a short response time. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? The fact that every new project creates a seperate database, so if you have many projects it has an impact on the systems performance and migrating to a later version of the system gets more difficult. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? It helps us with the digitalisation of the user requirements specification and so to achieve a paperless process while meet the global GMP and GDP guidelines. The collaboration with external suppliers is more transparent and consistent which makes the end-2-end process more efficient. Review collected by and hosted on G2.com. Show More Current UserValidated 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.) 8/28/2025 "Great tool – simple, intuitive, and backed by excellent support, even for small customers." 4/5 What do you like best about Aligned Element? Create different types of documents and document templates from the same underlying data easily. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? Sometimes it is a bit inconvenient to work with the word Add-in for documentation. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Traceability, document history, compliance with different norms and standards Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") AM Verified User in Medical Devices Small-Business (50 or fewer emp.) 8/25/2025 "Excellent tool for managing traceability requirements, very useful in medical development" 4/5 What do you like best about Aligned Element? Traceability, effective development patterns. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? The overall view of a group of requirements is not intuitive. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? Traceability and project tracking with a very large number of requirements. Quality of design tracking in the medical field. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: OrganicAI Translated ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") AM Verified User in Medical Devices Small-Business (50 or fewer emp.) 6/18/2025 "Review of Aligned Elements" 4/5 What do you like best about Aligned Element? The structure of relevant entities and the configurable tracing between them. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? Can be a bit slow if the project is large. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? With Aligned Elements we can be confident that we have complete traceability between requirements, tests, risks, mitigations etc. This is a requirement for approval of any medical device. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ![Swapnil M.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Swapnil M.") SM Swapnil M. Casual Team Member Small-Business (50 or fewer emp.) 1/13/2023 "Used by a physio company - recommend this software for all their medical device developments." 4/5 What do you like best about Aligned Element? Easier documentation, risk assessment, and design reviews are all streamlined with Aligned elements. Review collected by and hosted on G2.com. What do you dislike about Aligned Element? Manual test cases take a long time to process, and results take a while. Both these setbacks could be improved. Review collected by and hosted on G2.com. What problems is Aligned Element solving and how is that benefiting you? aligned elements is trying to streamline the process of medical device development. This is very useful as our physio systems need constant checks. Review collected by and hosted on G2.com. Show More Validated ReviewerIncentivizedSource: G2 invite ## 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);)