Aligned

Aligned develops software for the medical device sector. One product supports device development and the building of technical and design history files; the other runs the surrounding quality system.

What Aligned offers

• Aligned Elements — design control for medical devices, with requirements, ISO 14971 risk management, verification and validation test management, traceability and document management with electronic signatures.
• Gap checks — Aligned Elements flags missing traces and inconsistencies before an auditor finds them.
• Aligned eQMS — electronic quality management covering document control, training, change management and computer software validation.
• Quality events — handling of complaints, customer feedback, CAPAs, nonconformities and vigilance reports.
• Supplier, audit and equipment management — further modules within the eQMS.
• Extensions — connectors between Aligned Elements and other applications.

Who it works with

Medical device companies handling quality, compliance and technical documentation.

Key facts

• Based in: Switzerland
• Languages: English and German
• Standards: ISO 14971 risk management