aligned elements

aligned elements is application lifecycle management software for the medical device industry. It helps manufacturers create, manage and trace the design control items in their Design History File, so less time goes on regulatory paperwork.

What aligned elements offers

• Requirements management — Version control, reporting and customisation for device requirements.
• Risk management — Risk records kept alongside the rest of the design.
• Test management — Tests linked to requirements.
• Full traceability — All design control items are traced in a single application.
• Technical file support — Helps with writing the technical documentation.

Who it works with

Medical device companies aiming to get products approved.

Key facts

• Company range: Also sells Aligned eQMS, a quality management system
• Focus: Design control and Design History File management