Aligned AG

medical devices

About

Aligned AG, founded in 2006 and based in Zürich, Switzerland, specializes in software solutions for the medical device industry. The company offers Aligned Elements, a comprehensive Application Lifecycle Management (ALM) system tailored for the compliant development documentation of regulated medical products. Aligned Elements streamlines the development process by managing technical documentation and design control activities. It integrates all design control items into a single system, ensuring end-to-end traceability and automatic consistency monitoring. The software supports the creation and management of Design History Files (DHF) and Technical Files (TF), which are essential for regulatory submissions. It complies with key industry standards, including ISO 13485, ISO 14971, IEC 62304, and FDA regulations, helping medical device manufacturers reduce documentation burdens and accelerate their product development cycles. Aligned AG targets medical device manufacturers and developers, providing them with tools to enhance quality control and achieve faster market access through CE Mark and FDA approvals.

Technologies

Outlook Microsoft Office 365 Mobile Friendly Google Dynamic Remarketing Hotjar DoubleClick Conversion Nginx reCAPTCHA DoubleClick YouTube Google Tag Manager Node.js

Keywords

design history file management alm for medical devices risk management traceability matrix medical device documentation design control management technical file management technical documentation management requirements management medical equipment manufacturing product development regulatory standards regulatory wizard test case management electronic signatures automated traceability verification and validation medical equipment and supplies manufacturing b2b change impact analysis manufacturing linked projects regulatory compliance project branching and merging iso 13485 quality management system iso 14971 regulatory checklist medical device development iec 62304

Location

37 Klingenstrasse, Zurich, Zurich, Switzerland, 8005

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