The Best Way to Manage Your Design History File Traceability

Tailored to meet regulations such as EU IVD-D, EU MDD, FDA QSR 820, ISO 14971, ISO 13485 and cGMP.

Writing and managing Design History Files can be a cumbersome and time consuming task. However, keeping the content and the traceability of Requirements, Specifications, Tests and Risks up-to-date is crucial to every medical device manufacturer.

Aligned provides measures to ensure compliant development for regulated products in the medical device industry.

Try out "Aligned Elements" a software dedicated to make sure that your DHF's are complete and consistent at all times, using minimal effort and tying up a minimum of resources.

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