{"best_for":["Medical device manufacturers","R&D teams in healthcare","QA/RA professionals","Medical device engineering consultants"],"citation":{"dataset":"aitoolsforbusiness-agent-tool-export","directory_tool_url":"https://aitoolsforbusiness.ai/aligned-elements","json_profile_url":"https://aitoolsforbusiness.ai/data/tools/aligned-elements.json","markdown_profile_url":"https://aitoolsforbusiness.ai/data/markdown/tools-md-003.json","schema_version":"1.4.0","suggested_citation_label":"AI Tools for Business: aligned elements (https://aitoolsforbusiness.ai/aligned-elements)"},"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."],"freshness_status":"fresh","name":"aligned elements","pricing_note":"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.","pricing_url":"https://aligned.ch/pricing","primary_category":"Healthcare","profile_last_verified":"2026-06-05T09:16:01.469Z","secondary_categories":[],"short_description":"Aligned Elements provides design control and quality management software for medical device companies to manage technical files and regulatory compliance.","slug":"aligned-elements","sponsorship_status":"none","url":"https://aitoolsforbusiness.ai/aligned-elements","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."],"website_url":"https://alignedelements.com/"}