Aligned Elements: Medical Device Design Control and eQMS

Key Features

• Requirement Management

  Captures and controls requirements with a chronological audit trail of events.

• Risk Management

  Supports ISO 14971 risk assessments to identify, evaluate, and mitigate risks.

• Traceability Management

  Supports end-to-end tracing between requirements, risks, and tests.

• Test Management

  Supports the planning, execution, and documentation of hardware and software verification and validation.

• Document Control

  Manages document creation and approvals using electronic signatures and routing.

• Regulatory Compliance

  Provides templates and supports standards such as ISO 13485, FDA QSR 820, and EU MDR.

Use Cases

• Technical File Creation

  Supporting the development and documentation of Technical Files and DHFs for regulatory submissions.

• Audit Preparation

  Using traceability and consistency checks to identify gaps before regulatory audits.

• Quality Event Tracking

  Managing complaints, nonconformities, and CAPAs within a digital quality system.

• Supplier and Equipment Monitoring

  Tracking supplier approvals and equipment calibrations in a centralized location.

Integrations

• Jira
• TFS
• Enterprise Architect
• GitHub
• Excel import
• Word export
• Req-IF import
• XML import

FAQ

What industries is Aligned Elements designed for?

It is designed for the medical device industry, including manufacturers and sub-suppliers.

Does Aligned Elements offer a trial?

Yes, a 30-day free trial is available.

Can the software be installed on-site?

Yes, Aligned Elements offers on-premise deployment in addition to SaaS and cloud-hosted options.

What regulatory standards does the tool support?

It supports several standards, including ISO 13485, ISO 14971, IEC 62304, FDA QSR 820, and EU MDR.