Aligned Elements 🇨🇭

About the channel

The Aligned eQMS and Aligned Elements Design Control ALM software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle. Aligned products, designed for collaboration between quality, regulatory and R&D, combines a complete electronic Quality Management System with deep Design Control functionality in one integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections. AI driven traceability, impact analysis, and real time status views make it easy to demonstrate compliance and design control maturity to auditors and notified bodies.