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The faster way to medical devices compliance

Worldclass Design Control Management will accelerate your Technical File / Design History File completion

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Manage, review and release requirements during the entire Lifeycle
Any changes made are under strict version control with integrated change impact analysis

ISO 14971 Risk Management

Conduct top-down (Preliminary Hazard Analysis) and bottom-up (FMEA) ISO 14971 compliant risk assessments, tightly integrated in the traceability landscape

End to End traceability

Intuitive management of traces, combined with a clear visualization of the traceability status eliminates compliant problems and consistency issues

Create, manage and run automated and manual test cases and monitor the progress
Seamlessly integrate with your own bug tracking systems

With the industry's most powerful and flexible Word integration in your hands, digitize your Technical File / DHF document management

Automatically scan and monitor your project to detect and visualize gaps and trends in the consistency and completeness of your DHF

Is your team held up by documentation work when it should innovate state-of-the-art medical devices?
Medical Device companies report that up to 30% of the total development effort is spent on documentation activities

Aligned Elements integrates and traces all Design Control Items in your application lifecycle into one single application

Eliminate manual merging and mapping across separate systems and rely on automatic consistency monitoring to drive out quality errors

Fast track to regulatory approval