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DHF Management Today

Discover how "Aligned Elements" keep your Design History Files consistent, complete and compliant.

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The Best Way to Manage Your Design History File Traceability

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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.

News

June 2010
Aligned Elements V1.7 released
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June 2010
Levitronix releases new CentriMag
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May 2010
Tecan reduces DHF set-up time with up to 80%
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    Read more about what our clients have to say about their own experiences using Aligned Products and services.

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