Aligned Elements: Medical Device Design Control and eQMS
Aligned Elements helps R&D and QA/RA teams in medical device companies manage design controls and regulatory documentation. It is designed for teams maintaining a Design History File (DHF) and requiring traceability for FDA or ISO audits.
At a glance
- Category
- Healthcare
- Best for
- Medical device manufacturers, R&D teams in healthcare, QA/RA professionals, Medical device engineering consultants
- Pricing
- SaaS pricing starts at 650€ per month for Design Control ALM. eQMS packages range from 1000€ to 2085€ per month. A 30-day free trial is available.
- Key use cases
- Technical File Creation, Audit Preparation, Quality Event Tracking, Supplier and Equipment Monitoring
- Integrations
- Jira, TFS, Enterprise Architect, GitHub, Excel import
- Official website
- alignedelements.com
Aligned Elements consists of a toolset for design control (ALM) and quality management (eQMS). It is designed for the medical device industry to help teams organize requirements, risks, and tests into a compliant Technical File.
Key Features
Captures and controls requirements with a chronological audit trail of events.
Supports ISO 14971 risk assessments to identify, evaluate, and mitigate risks.
Supports end-to-end tracing between requirements, risks, and tests.
Supports the planning, execution, and documentation of hardware and software verification and validation.
Manages document creation and approvals using electronic signatures and routing.
Provides templates and supports standards such as ISO 13485, FDA QSR 820, and EU MDR.
Use Cases
Supporting the development and documentation of Technical Files and DHFs for regulatory submissions.
Using traceability and consistency checks to identify gaps before regulatory audits.
Managing complaints, nonconformities, and CAPAs within a digital quality system.
Tracking supplier approvals and equipment calibrations in a centralized location.
Best For
Integrations
Pricing
SaaS pricing starts at 650€ per month for Design Control ALM. eQMS packages range from 1000€ to 2085€ per month. A 30-day free trial is available.
FAQ
It is designed for the medical device industry, including manufacturers and sub-suppliers.
Yes, a 30-day free trial is available.
Yes, Aligned Elements offers on-premise deployment in addition to SaaS and cloud-hosted options.
It supports several standards, including ISO 13485, ISO 14971, IEC 62304, FDA QSR 820, and EU MDR.
Source category: Healthcare
Source subcategory: Design Control Management
Software Type:
How AI is used
Aligned Elements provides design control and eQMS software for medical device companies. It supports the creation of compliant Technical Files and DHFs through requirement and risk management. Buyers should note that the system requires individual validation based on their specific configuration.
Pros & Cons
- Specialized for medical device regulatory standards
- Offers SaaS and on-premise deployment options
- Includes pre-configured SOPs and templates
- Flexible licensing including floating and review licenses
- Software requires validation by the buyer as it is highly configurable
- Full QMS capabilities are available only in higher-tier eQMS packages
