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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September 16 2016

The 2016 "Documentation Trends and Insights in Medical Device Documentation" survey is live!

Are you alone in experiencing challenges when it comes to Medical Device Documentation? Or is what you feel shared by the industry?

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We invite you as a Medical Device professional to share your thoughts on the state of documentation practices by participating in this survey.

The survey will assess how Medical Device organisations manage regulatory driven documentation challenges during the R&D phase.

Take the 2016 Medical Device Documentation Survey now!

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