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

April 01 2014

We have been following an interesting discussion on Linked In "How far is possible"  (this link can only be viewed if you are a group member: Medical Devices: QA / RA discussion 'How far is possible?') as a result of the 14971:2012 Annex ZA deviation #3.

In this discussion mr Singh linked to an informative presentation http://goo.gl/QJiUZj on the subject.

Most companies that participated in the discussion have updated thier processes to avoid the term ALARP, usually also no longer identifying any 'Acceptable' ranges of risks. The driver seems rather to be to comply with what notified bodies expect to see. All still acknowledge that there will always be the notion of an economical parameter when deciding on risk mesures. The arguments backing why the risk measures weren't taken even further where recommended to be an analysis of Risk vs Benefit and caliming that the risk measures are 'State of the Art'

 

howFarIsPossible

 

 

 

 

March 28 2014

Since the release of Aligned Elements V2.1 SP 1, it is possible integrated Work Item lists from your existing Team Foundation Server in Aligned Elements.

With the appropriate configuration, coupling your Aligned Elements user with your TFS user, your Work Items dynamically appear in a separate Item view. 

TFS

In Aligned Elements, the Work items behave and are treated very much like regular Document Objects, meaning that you can open and edit them in a Document Object form, set traces to them, set up inconsistency rules for real-time checks etc.

TFS2

When saving changes made to a Work Item in Aligned Elements, the attribute changes are routed to the TFS server, effectively separating the two repositories according to their respective responsibilities. 

Using the "Go to Original" link in the Document Object Form automatically opens a browser and navigates to the Work Item on your TFS server.

TFS3

Using the Aligned Element TFS integration, permits you to benefit from your existing Team Foundation System infrastructure in the Design History File management, working smoother, faster and with less interuptions.

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 (2.1.28.9239).

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.

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