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

May 01 2014

70Percent

Meet us at Medtec Europe on Thursday June 5th this summer.

Our co-worker Karl Larsson speaks about "Test and V&V Plan Execution and documentation of test reports" at Track B betwen 15:00 and 15:45 in the context of "Risk, Quality and Validation".

More information under this link.

April 29 2014

Zühlke Engineering AG in Zürich (http://www.zuehlke.com), are currently evaluating Aligned Elements for use in their product development.  

“We were excited when we found Aligned Elements, since we have a large segment of Medical device projects.", says Claudio Schödler, Project Manager at Zühlke. 

"Currently, we are running a smaller in-house project where all design items are captured in Aligned Elements. All created documents will later on be delivered to the end customer. The initial effort has been exceptionally small since the tool is easily configurable and really focuses on everyday tasks.", Mr Schödler continues. "The evaluation will continue until the summer and will be concluded in an evaluation report.”

We at Aligned are looking forward to the evaluation report and any insights from the skilled Zühlke team!

April 15 2014

On April 16th, 2014, we release Aligned Elements V2.1 Service Pack 2 (2.1.35.9472).

Aligned Elements V2.1 SP 2 is focusing on bug-fixes and ships with 30+ fixes.

This service pack also includes some minor fixes requested by our users, in particular in the area of risk reporting.

Aligned Elements V2.1 SP 2 can be downloaded here.

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.

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