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.
Average Rating: 4.5/5.0
Total Reviews: 12
How Do G2 Users Rate Aligned Element?
- Stakeholder Communication: 5.0/10 (Category avg: 8.6/10)
- Requirements Listing: 6.7/10 (Category avg: 9.2/10)
- Internal Communication Enablement: 6.7/10 (Category avg: 8.9/10)
- Ease of Use: 7.8/10 (Category avg: 8.7/10)
Who Is the Company Behind Aligned Element?
- Seller: Aligned AG
- Year Founded: 2006
- HQ Location: Zurich
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LinkedIn® Page: www.linkedin.com
5 employees on LinkedIn®
Who Uses This Product?
- Top Industries: Medical Devices
- Company Size: 50% Small, 42% Medium
What Do G2 Reviewers Say About Aligned Element?
AI-generated summary from verified user reviews
Pros
- Users value the automation capabilities of Aligned Elements, which enhance efficiency and streamline design requirements management.
- Users value the exceptional customer support from Aligned Elements, with prompt responses enhancing their overall experience.
- Users value the tracking efficiency of Aligned Element, enhancing compliance and simplifying documentation processes effectively.
- Users value the detailed audit trail provided by Aligned Elements, enhancing transparency and accountability in their workflows.
- Users value the intuitive document control of Aligned Element, enhancing productivity with organized and compliant documentation.
Cons
- Users find the Word Add-in inconvenient for documentation, especially with fitting information into various screen sizes.
- Users find formatting issues, especially with multilevel numbering in test plans, frustrating in Aligned Element.
- Users find the learning curve challenging initially, particularly with integrations and reporting setup, but it improves with use.
- Users experience a learning difficulty initially, especially with integrations and dataset preparations for Power BI.
- Users find limited accessibility challenging when fitting information into various screen sizes, despite recent improvements in Aligned Elements.
What Are Recent G2 Reviews of Aligned Element?
"Aligned Elements: A powerful tool for ensuring quality and good procedures"
Rating: 5.0/5.0 stars
— Malena C.
Rating: 4.5/5.0 stars
— Sam A.

