Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management.

February 07 2014

Join us as we reveal some of the hard learned best practices of medical device development on Tuesday March 4th.

Together with Emenda, Aligned AG presents this half-day seminar at Marriott Courtyard Oerlikon on how improvements in testing and development documentation will make a significant positive impact on your medical device development process.

The presentations for the seminar are available for download below:

 > Emenda - FDA Software Development: bottlenecks and challenges

 > Aligned - Design History File Bad Practices

 > Aligned - Automated Design History File Management

January 31 2014

On January 31st, 2014, we release Aligned Elements V2.1 Service Pack 1 (

Aligned Elements V2.1 SP 1 contains a number of new significant improvements in Aligned Elements Word integration, most notably: 

  1. Optional usage of several Word template sets in a single project 
  2. Optional display of all linked objects in Word Project Explorer 
  3. Forced update of Word documents
  4. Support for MS Word x64 bit installations 
  5. Support for .docm files

This release also includes: 

  • Microsoft TFS Integration
  • Query RPN filter for Objects below and above a certain RPN
  • Query RPN Threshold filter for Document Objects above/below a defined thresholds

Aligned Elements V2.1 SP 1 builds on the improved feature set of AE V2.1 which strengthens Aligned Elements claim to the leading position of Design History File Management solution providers.

October 25 2013

Biocartis, medical device manufacturer and developer of the PCR platform Idylla, has chosen Aligned Elements to manage the Design History File.

Idylla is a compact and scalable molecular diagnostics platform that allows assays to be performed anywhere, anytime without the need for a specialist laboratory environment and trained technicians.

IdyllaTM rapidly detects biomarkers in cancer samples, amongst other clinical patient samples, with a much higher sensitivity as compared to standard diagnostic assays and standard sequencing.

Find more information about Biocartis here.

August 30 2013

On August 30th, 2013, we release Aligned Elements V2.1 (

Aligned Elements V2.1 is the new major release from Aligned AG, containing a number of new features for increased control and improved transparency. These include:

  • Breakdown Charts with drilldown capability
  • Consistency Coverage Summary
  • Generation of trace reports to Excel
  • MS Word 2013 compatibility
  • Category Filtering in Project Explorer
  • Integration support for the Countersoft Gemini Issue Tracker

This improved feature set strengthens Aligned Elements claim to the leading position of Design History File Management solution providers.


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