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aligned elements Logo

Quality management solution

Table of Contents

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aligned elements - 2026 Pricing, Features, Reviews & Alternatives

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aligned elements overview

What is aligned elements?

aligned elements is a quality management solution designed for managing the lifecycle of medical device applications, focusing on design history file and technical file management. It assists medical device manufacturers in meeting regulatory requirements during product development.

The platform includes features for comprehensive requirements management with version control, risk management compliant with ISO 14971, and test management for verification and validation activities. It offers end-to-end traceability, connecting all design control items and providing clear visualization of traceability status. The document management component integrates with MS Word for technical documentation, facilitating streamlined approvals and signatures. Automatic scanning and monitoring help detect gaps and inconsistencies to prevent compliance issues.

aligned elements supports regulatory compliance with frameworks for medical device standards such as ISO 13485:2016, ISO 14971:2019, IEC 62304:2015, FDA QSR 820, EU MDR/IVDR, and IEC 60601-1. Organizations can choose from deployment options including cloud-hosted, on-premises, or software as a service solutions to suit their infrastructure needs.

Key benefits of using aligned elements

  • The system streamlines design control and documentation for medical devices to accelerate time to market.
  • It provides end-to-end traceability to eliminate compliance issues and consistency errors.
  • The platform includes built-in support for key regulations, such as ISO 13485, IEC 62304, and FDA 21 CFR 820 QSR.
  • Starting price

    1300per user /
    per year

    Alternatives

    with better value for money

    aligned elements’s user interface

    Ease of use rating:

    aligned elements reviews

    Overall rating

    4.1

    /5

    14

    Positive reviews

    86

    %

    Rating breakdown
    • Value for money
    • Ease of use
    • Features
    • Customer support
    • Likelihood to recommend7.78/10
    Rating distribution

    5

    4

    3

    2

    1

    3

    9

    2

    0

    0

    Pros
    “Using it also for non-medical products. Wherever good requirements management is important, I would recommend Aligned.”
    FP

    Filip P.

    PMO

    “I really like the personal support and the ease of use and tweakability.”
    FD

    Froukje D.

    Quality Manager

    “Excellent support in case of questions and issues. I always got a solution.”
    RK

    Reinhard K.

    Manager IT and Infrastructure

    Cons
    “Poor team collaboration as well as limitations in the adaptation of the AE with other tools.”
    JP

    Jaimin P.

    Regulatory Affairs Manager

    “As with every piece of software you encounter once in a while a problem, but in these cases the guys from Aligned are there within no time to resolve your issue.”
    BB

    Beat B.

    Senior Verification Engineer

    “Furthermore it provides an integrated risk management module to connect the risk analysis points directly and easily with effected requirements and vice versa.”
    SH

    Stefan H.

    Software Engineer

    Who uses aligned elements?

    Based on 14 verified user reviews.

    Company size

    Small Businesses

    Enterprises

    Midsize Businesses

    Top industries

    Medical Devices
    Biotechnology
    Nanotechnology

    Use cases

    Requirements Management
    Application Lifecycle Management
    Quality Management
    Compliance

    aligned elements's key features

    Most critical features, based on insights from aligned elements users:

    Traceability
    Change management
    Document management
    Task management
    Collaboration tools
    Status tracking

    All aligned elements features

    Features rating:

    Access controls/permissions
    Quality control
    Testing/QA management
    Test Run Tracking
    Test Case Tracking
    Document coding & control
    Issue management
    Document storage
    Workflow management
    Project workflow
    Project tracking
    Project planning
    Progress tracking
    Prioritization
    Policy management
    Multiple projects
    Maintenance management
    Lifecycle management
    Iteration management
    ISO standards management
    ISO compliance
    Commenting/Notes
    Version control
    Training management
    Third-Party integrations
    Test Library Maintenance
    Template management
    Task progress tracking
    Task Planning
    Supplier quality control
    Stakeholder defined attributes
    Risk management
    Risk assessment
    Requirements Review
    Requirements management
    Reporting/Analytics
    Reporting & statistics
    Real-Time updates
    Real-Time data
    Bug tracking
    Baseline manager
    Automatic Test Generation
    Audit trail
    Audit management
    Assessment management
    Archiving & retention
    Approval process control
    Application management
    API
    Alerts/Notifications
    Alerts/Escalation
    Agile methodologies
    Administrator Level Control
    Activity tracking
    Activity dashboard
    @mentions
    Incident management
    For developers
    File management
    FDA compliance
    Equipment management
    Drag & drop
    Deliverables Management
    Defect tracking
    Data import/export
    Customizable templates
    Customizable reports
    Customizable fields
    Corrective and preventive actions (capa)
    Configurable workflow
    Compliance tracking
    Compliance management
    Complaint management
    Communications management

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    Starting from

    1300

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    Per year

    Free trial
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    Features
    Value for Money
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    aligned elements pricing

    Value for money rating:

    Starting from

    1300

    /user

    Per year

    Pricing details
    Subscription
    Free trial
    Free plan
    Pricing range

    User opinions about aligned elements price and value

    Value for money rating:

    To see what individual users think of aligned elements's price and value, check out the review snippets below.

    “Using it also for non-medical products. Wherever good requirements management is important, I would recommend Aligned.”
    FP

    Filip P.

    PMO

    “I really like the personal support and the ease of use and tweakability.”
    FD

    Froukje D.

    Quality Manager

    aligned elements integrations (7)

    aligned elements support options

    Typical customers

    Freelancers
    Small businesses
    Mid size businesses
    Large enterprises

    Platforms supported

    Web
    Android
    iPhone/iPad

    Support options

    Email/Help Desk
    FAQs/Forum
    Phone Support

    Training options

    Live Online
    In Person
    Documentation
    Videos

    aligned elements FAQs

    Q. What type of pricing plans does aligned elements offer?

    aligned elements has the following pricing plans:
    Starting from: €1300.00/year
    Pricing model: Free, Subscription
    Free Trial: Available | (No Credit Card required)

    These products have better value for money


    Q. Who are the typical users of aligned elements?

    aligned elements has the following typical customers:
    Large Enterprises, Mid Size Business, Small Business


    Q. What languages does aligned elements support?

    aligned elements supports the following languages:
    English


    Q. Does aligned elements offer an API?

    Yes, aligned elements has an API available for use.


    Q. What other apps does aligned elements integrate with?

    aligned elements integrates with the following applications:
    GitHub, Enterprise Architect, Redmine, Jira, GitLab, Azure DevOps Server


    Q. What level of support does aligned elements offer?

    aligned elements offers the following support options:
    Email/Help Desk, FAQs/Forum, Phone Support

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