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

November 21 2017

Last week we met up with some of the Swiss Aligned Elements users at the Aligned Elements User Conference 2017. It was a very rewarding occasion for me and our team. For ten years, we have grown together with our customers and many of the best improvements we have done to Aligned Elements, are ideas from our customers.

It is not always about new features

It is easy to get locked into the thought process of adding new features as an ISV. However, this user gathering underlined how much unlocked potential lies in slightly tweaking existing features, features that might not look very impressive on the surface but still has an enormous impact on the usability due to its frequent use. For us it was a real eye opener to hear about the large impact of two small features called "Reset Format" and "Paste as Plain Text". The participants had some good suggestions for improvements that we certainly will implement for the next service pack.

Different Users have different needs

As the discussion went on, it became clear that the needs of the groups "Frequent Users", "Infrequent Users" and "Administrators" are quite different. Whereas the Administrator representatives requested better support for User Management and changes made over large Project sets, the Infrequent Users were in greater need of clearer work instructions and an interface adapted to their specific tasks. One user compared Aligned Elements with Photoshop, "if you are a power user, Aligned Elements is extremely powerful, but if you only log in every six months to tick of tasks assigned to you, the interface is intimidating and do not do much to guide this user." We have great ideas in this area that we hope to be able to include in our next version.

Follow that document

Several users pointed out that Document Management, Review, Release and Sign-off actions have potential for improvements, both in scope and implementation details. This is something we are aware about and the user feedback delivered during the conference was very helpful on these points.

We are grateful to the participants for having joined this year's User Conference and will do our best to incorporate the improvements and suggestions in future Aligned Elements releases.

November 11 2017

The IVDR (Regulation EU 2017/746), published in the EU Official Journal on May 5th, will have a significant impact on the manufacturers making IVDR products. 

IVDR EU Regulation 2017 746

The BSI Group calls the new risk classification in the IVDR  a “quantum leap” for products that could have been self-certified under the old directive to products soon needing notified body certification under the new regulation. Access to notified bodies has been  identified as a major bottleneck in the years to come.

IVD companies targeting the european market should therefore move swiftly and resolutly if they desire to stay in business. Compiling the Technical File could be one such task.

The EU IVDR Annex I General Safety and Performance Requirements section corresponds to the Essential Requirements section in MDD Annex I.

If you want to check how your current Technical Files complies with these Requirements, you can download our check list here:

IVDR (EU 2017/746) Annex I General Safety and Performance Requirements

Just like the MDR Annex I General Requirements, the IVDR Annex I counterparts are also available to Aligned Elements users as a free extension.

IVDR Annex I Requirements can be imported as Design Control into any of your Aligned Elements projects and included in the traceability. The extension corresponds to the requirements in the 31 page check list and are made readily available in your traceability in a matter of seconds!

Kickstarting your Technical File compilation with the IVDR Annex I General Requirements extension, available to Aligned Elements user in order to helps them accelerate their medical device Design Control documentation effort. Browse through the available extensions and discover how they could accelerate your project.

The extension is available here: IVDR (EU 2017/746) Annex I Extension

November 06 2017

What's New

Continued integration with external systems has been the theme of this release. We are glad to have incorporated GitHub tickets in our ecosystem. Operating with Linked Projects has now also become easier.

Hello, GitHub!

We are finally integrating towards the tickets of the most popular source code control system on the planet! The GitHub integration allows you to create, modify and trace towards GitHub Tickets e.g. when you are performing your Tests.

GithubBig

 

Web Client Usability

Improved linked project support as well as the display of Help Texts have been implemented in this release.

HelpText

 

Starting external processes

Via Workflows, it is now possible to start external processes, triggered by events in Aligend Elements. These external processes can be fed with Aligned Elements content for further processing.

adam

 

What's Changed

  • A new Inconsistency rule detecting obsolete traces
  • Default texts in Table attributes
  • Renaming of Files in Web Client
  • Creating Projects with templates in Azure File Storage
  • Optional automatic updates of linked traces

Upgrade now

With important fixes and a handfull improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 3 here.

September 12 2017

Cybersecurity issues resulted in 465 000 St Jude pacemakers being subjected to a FDA recall due to fears of exploiting existing cybersecurity vulnerabilities in the device. A security hole exposes the device to hacking risks, potentially resulting in running the batteries down or even alter the patient’s heartbeat.

pacemaker

Although the risk is extremly low, the cost for St Jude / Abbott is significant. For a smaller firm these ramifications can be detrimental. The long life time of medical devices and an ever evolving cybersecurity arena makes devices vulnerable to cyber risks. Handling them effectively will be a significant challenge for the industry in the years to come.

We are addressing Cybersecurity issues in the Supply Chain during a Key note at the Swiss Medtech Expo in Luzern, 19-20 September.

Join us for this key note or come and meet us at the Expo at Booth B2045, Halle 02.

September 07 2017

Aligned will  present at the Swiss Medtech Expo in Lucern from 19-20 September!

Come and meet us at the Expo at Booth B2045, Halle 02 and discover the possibilities you have to reduce time and money spent on Design Control Documentation.

Let us explain you the idea behind the Aligned Elements and how other medical device manufacturers have saved up to 60% of their documentation maintenance effort. 

cms mf download 2 datei

To get your free ticket, click here: Free Entry Ticket Swiss Med Tech Expo

Find more information about the Expo here.

 

 

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