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DHF Management Today
Discover how "Aligned Elements" keep your Design History Files consistent, complete and compliant.
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.
News
December 2011
Aligned Elements Importer for Word and CSV files released
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November 2011
Major oncology player opts for Aligned Elemens
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October 2011
Aligned Elements V1.7 SP 4 out now
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August 2011
Thoratec acquires Levitronix medical division
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