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aligned elements
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Based on GetApp‘s extensive, proprietary database of in-depth, verified user reviews
Quality management solution
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aligned elements - 2026 Pricing, Features, Reviews & Alternatives
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Last updated: March 2026
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.
aligned elements’s user interface
aligned elements reviews
Overall rating
4.1
/5
14
Positive reviews
56
%
- Value for money
- Ease of use
- Features
- Customer support
- Likelihood to recommend0.56/10
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Who uses aligned elements?
Based on 14 verified user reviews.
Company size
Small Businesses
Enterprises
Midsize Businesses
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Use cases
aligned elements's key features
Most critical features, based on insights from aligned elements users:
All aligned elements features
Features rating:
aligned elements alternatives
aligned elements
Starting from
1300
/user
Per year
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920
Per month
Process Street
Starting from
No pricing info
aligned elements pricing
Value for money rating:
Starting from
1300
/user
Per year
User opinions about aligned elements price and value
Value for money rating:
aligned elements integrations (6)
Top integrations
aligned elements support options
Typical customers
Platforms supported
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Training options