List of Aligned Elements Customers
Zurich, 8005,
Switzerland
Since 2010, our global team of researchers has been studying Aligned Elements customers around the world, aggregating massive amounts of data points that form the basis of our forecast assumptions and perhaps the rise and fall of certain vendors and their products on a quarterly basis.
Each quarter our research team identifies companies that have purchased Aligned Elements for Application Lifecycle Management from public (Press Releases, Customer References, Testimonials, Case Studies and Success Stories) and proprietary sources, including the customer size, industry, location, implementation status, partner involvement, LOB Key Stakeholders and related IT decision-makers contact details.
Companies using Aligned Elements for Application Lifecycle Management include: Tecan, a Switzerland based Life Sciences organisation with 3315 employees and revenues of $1.18 billion, Biotronik, a Germany based Healthcare organisation with 9000 employees and revenues of $1.10 billion, Sony Network Communications Europe Sweden, a Sweden based Communications organisation with 35 employees and revenues of $8.0 million and many others.
Contact us if you need a completed and verified list of companies using Aligned Elements, including the breakdown by industry (21 Verticals), Geography (Region, Country, State, City), Company Size (Revenue, Employees, Asset) and related IT Decision Makers, Key Stakeholders, business and technology executives responsible for the software purchases.
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| Logo | Customer | Industry | Empl. | Revenue | Country | Vendor | Application | Category | When | SI | Insight |
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Biotronik | Healthcare | 9000 | $1.1B | Germany | Aligned Elements | Aligned Elements | Application Lifecycle Management | 2021 | n/a |
In 2021, Biotronik Vascular Intervention implemented Aligned Elements to integrate design control, requirements, risk and test management for Technical File and Design History File creation in Germany. The deployment addressed the Apps Category .
Aligned Elements was configured for design control workflows, requirements capture, risk management and test case management to create end to end traceability for product development artifacts. Configuration focused on linking requirements to risk items and test cases, maintaining traceability matrices and supporting Technical File and DHF assembly for vascular intervention devices.
The implementation covered the Vascular Intervention unit with operational scope in Germany, aligning engineering, regulatory affairs and quality management workflows to a single system of record. Integrations with other enterprise systems are not specified in the customer case, the work centered on embedding Aligned Elements into product development and regulatory documentation processes.
Governance changes included standardized design control processes and centralized traceability to reduce duplicated manual work across teams, with Aligned Elements serving as the repository for requirements, risk and test evidence. The customer case states the implementation improved traceability and reduced duplicated manual work while supporting Technical File and DHF deliverables.
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Sony Network Communications Europe Sweden | Communications | 35 | $8M | Sweden | Aligned Elements | Aligned Elements | Application Lifecycle Management | 2018 | n/a |
In 2018 Sony Network Communications Europe Sweden implemented Aligned Elements to support the mSafety wearable and remote monitoring project and to meet ISO 13485 and IEC 62304 regulatory requirements across its Nordic operations, with the Apps Category "". The implementation timeline is an estimate based on published vendor customer materials that explicitly reference ISO 13485 and IEC 62304 support for the mSafety customer story.
Aligned Elements was configured to support formal requirements capture, bidirectional requirements traceability, and structured document control to preserve audit trails for regulatory submission and quality management. The deployment emphasized requirements management, verification and validation artifact association, and change control workflows consistent with medical device software lifecycle practices, using Aligned Elements as the central repository for requirements and compliance evidence.
Operational coverage focused on product engineering, regulatory affairs, and quality assurance functions within Sony Network Communications Europe Sweden’s Nordic operations. Governance incorporated controlled review and approval gates, traceability reporting for audits, and role-based access to maintain evidence integrity for ISO 13485 and IEC 62304 compliance.
Vendor documentation is cited as the source for regulatory alignment claims, and the implementation is described in vendor materials as improving compliance and traceability for the mSafety project. No system integrator is named in the available materials.
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Tecan | Life Sciences | 3315 | $1.2B | Switzerland | Aligned Elements | Aligned Elements | Application Lifecycle Management | 2019 | n/a |
In 2019, Tecan AG implemented Aligned Elements to modularize Design History File documentation and centralize regulatory artifact management. Aligned Elements, Apps Category: , was deployed to support product documentation and regulatory engineering workflows in Switzerland, with an explicit objective to reduce duplication across product modules and improve reuse and efficiency.
The implementation emphasized modular DHF creation using Aligned Elements capabilities for linked projects and traceability, configuring project templates and reusable module artifacts to represent common design inputs and outputs. The deployment leveraged the application s traceability matrices and linked-projects feature to maintain requirement to design output linkage across multiple product modules, and to manage versioning and audit trails for regulatory submissions.
Operational scope focused on regulatory documentation and product engineering teams in Switzerland, where rollout included standardized module templates, governance around traceability practices, and process changes to authoring and review cycles. The implementation produced documented reductions in duplication and increased reuse and efficiency in Switzerland, aligning Aligned Elements with Tecan s regulatory documentation and quality assurance practices.
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Buyer Intent: Companies Evaluating Aligned Elements
- Aligned Switzerland, a Switzerland based Life Sciences organization with 10 Employees
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