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.

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.

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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. 

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

Find more information about the Expo here.

 

 

February 09 2017

Our friends at Qadvis has grown steadily over the last couple of years and this is no wonder.

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These guys are co-authors of many of the standards you use today. If you have questions about ISO 13485, IEC 62304, IEC 80001-1 or IEC 60601-1, who would be better to ask than the person who actually penned it? 

I can highly recommend their services and advice. Just recently the Qadvis Team put together a ton of Quality and Regulatory material for download on their website. For free!

Go take a look!

 

September 29 2016

We are participating in the Med Conf 2016 25-28 October with our lecture "Death by Documentation - how to identify documentation inefficiencies in your medical device development process"

If you ar interested in how to assess the documentation process in order to find process inefficiencies in your own company, then this one is for you!

The lecture is held by our CEO Anders Emmerich on 27. October at 14:10.

Find the complete agenda here.

If you want to meet us during the conference, please This email address is being protected from spambots. You need JavaScript enabled to view it. and we'll set up an appointment!

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