# Aligned Element Reviews **Vendor:** Aligned AG **Category:** [Medical Quality Management Systems (QMS)](https://www.g2.com/categories/medical-qms) **Average Rating:** 4.5/5.0 **Total Reviews:** 12 ## About Aligned Element 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. ## Aligned Element Pros & Cons **What users like:** - Users value the **automation features** of Aligned Elements, enhancing efficiency in managing design requirements and documentation. (3 reviews) - Users value the **exceptional customer support** from Aligned Elements, appreciating prompt responses and effective assistance. (3 reviews) - Users value the **tracking efficiency** of Aligned Element, benefiting from streamlined compliance and robust support in medical device design. (3 reviews) - Users value the **detailed audit trails** in Aligned Elements, enhancing accountability and transparency in design requirements management. (2 reviews) - Users appreciate the **easy document creation and template management** in Aligned Element, enhancing productivity with intuitive organization. (2 reviews) - Ease of Use (2 reviews) - Features (2 reviews) - Users appreciate the **intuitive interface** of Aligned Element, simplifying navigation through complex documentation with ease. (2 reviews) - Structure (2 reviews) - Accessibility (1 reviews) **What users dislike:** - Users find the **Word Add-in for documentation inconvenient** , especially when fitting information into various screen sizes. (2 reviews) - Users experience **formatting issues** with test plans, notably with multilevel numbering capabilities in Aligned Element. (1 reviews) - Users experience a **steep learning curve** initially, particularly with integrations and data formatting for reporting. (1 reviews) - Users report a **learning difficulty** initially, particularly with integrations and manual dataset formatting, hindering onboarding. (1 reviews) - Users find **limited accessibility** on different screen sizes challenging, despite updates aimed at improving scalability. (1 reviews) - Users find the **training module lacking depth** , needing improvement to match the polish of the rest of Aligned Element. (1 reviews) - Users find the **navigation not intuitive** in Aligned Element, making tasks like document creation cumbersome. (1 reviews) - Slow Performance (1 reviews) - User Difficulty (1 reviews) - UX Improvement (1 reviews) ## Aligned Element Reviews ### 1. A fantastic tool for managing design requirements, verification and validation activities, and more **Rating:** 4.5/5.0 stars **Reviewed by:** Sam A. | Senior Quality Engineer - Team Lead, Mid-Market (51-1000 emp.) **Reviewed Date:** August 26, 2025 **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. **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. **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. ### 2. Aligned Elements: A powerful tool for ensuring quality and good procedures **Rating:** 5.0/5.0 stars **Reviewed by:** Malena C. | Quality Engineer, Small-Business (50 or fewer emp.) **Reviewed Date:** June 05, 2025 **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. **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. **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. ### 3. Handy tool, easy traceability, great customer service! **Rating:** 5.0/5.0 stars **Reviewed by:** Louis S. | QARA Engineer, Mid-Market (51-1000 emp.) **Reviewed Date:** June 19, 2025 **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. **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. **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! ### 4. Makes regulatory reporting easier with well-organized data **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Hospital & Health Care | Mid-Market (51-1000 emp.) **Reviewed Date:** June 17, 2025 **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. **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. **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. ### 5. Director of Engineering Operations & Program Management **Rating:** 5.0/5.0 stars **Reviewed by:** Angie L. | Project Engineer, Mid-Market (51-1000 emp.) **Reviewed Date:** June 04, 2025 **What do you like best about Aligned Element?** Trace tables to create Input/Output matrices. **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. **What problems is Aligned Element solving and how is that benefiting you?** Traceability of inputs and outputs for Design History File documentation. ### 6. Creating trace reports and risk assessment documents **Rating:** 4.5/5.0 stars **Reviewed by:** st t. | Process Co-ordinator, Mid-Market (51-1000 emp.) **Reviewed Date:** June 10, 2025 **What do you like best about Aligned Element?** Tracking traces, flexibility and designing custom-made work items, quick support **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 **What problems is Aligned Element solving and how is that benefiting you?** Creation of trace reports especially among multitude of linked projects. ### 7. Assistance with Import/Export of Requirements **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** June 16, 2025 **What do you like best about Aligned Element?** Logical workflow, aligns well with my needs. **What do you dislike about Aligned Element?** Have not used AE long enough to have an opinion on this. **What problems is Aligned Element solving and how is that benefiting you?** Managing multiple levels of requirements within a class 3 medical device system. - [View Aligned Element pricing details and edition comparison](https://www.g2.com/products/aligned-element/reviews?filters%5Bnps_score%5D%5B%5D=5§ion=pricing&secure%5Bexpires_at%5D=2026-06-12+21%3A55%3A10+-0500&secure%5Bsession_id%5D=31413487-62f4-476f-9b82-64eabae83e72&secure%5Btoken%5D=c10c05d535bbd8cff30cb0ece076a2d514284ad05b266858f63bae5d0c993ac0&format=llm_user) ## Aligned Element Integrations - [Jira](https://www.g2.com/products/jira/reviews) - [Microsoft Word](https://www.g2.com/products/microsoft-word/reviews) ## Aligned Element Features **Quality Management** - Design Controls - Audit Management - Supplier Network Management - Risk Management **Core Lifecycle Management - ALM Software** - Test Management - Traceability - Requirements Management **Requirements Authoring and Structure - Requirements Management** - Structured Requirements Authoring - Hierarchical Requirements Organization **Compliance and Governance - Requirement Management** - Regulated Industry Standards Support **Quality System** - Analytics & Reporting - Real-time Collaboration - Document Control - Quality Processes **Administration** - Requirements Listing - Centralized Information - Traceability **Organization - ALM Software** - Reporting - Collaboration - Project Planning **Collaboration and Review - Requirements Management** - Review and Approval Workflows - Role-Based Access Control **Communication** - Stakeholder Communication - Internal Communication Enablement **Role-Based Access Co - Requirements Management** - Baselining **Procedural** - Automated Creation & Testing **Traceability - Requirements Management** - Bidirectional Traceability - Impact Analysis - Traceability Matrix Generation **AI Traceability - Requirements Management** - Suspect Link Detection **Integration - Requirements Management** - ALM and Project Management Tool Integration **Change Management and Version Control - Requirements Management** - Complete Audit Trail ## Top Aligned Element Alternatives - [Qualio](https://www.g2.com/products/qualio/reviews) - 4.4/5.0 (749 reviews) - [Octave Reliance (ETQ Reliance)](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) - 4.3/5.0 (596 reviews) - [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) - 4.3/5.0 (521 reviews)