April 01 2018

 

Sharpen your Skills 2018

May 17th, 2018 | HWZ University, 3 minutes from Zürich Main Station

Skills

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2018.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.


Key Learning Objectives

Medical Device IT Security

Live hacking session, an introduction to the regulatory requirements and hands-on tips for developers of medical devices - by Prof. Dr. Christian Johner, CEO, Johner Institute

Implementing GDPR at Polar

Learn more about how Polar implemented one of the most important regulatory changes in 2018. If you haven't started yet, get the do's and don's from Niclas Granqvist, Director Apps & Electronics, Polar Electro Oy

Common Usability Engineering Pitfalls

What could possible go wrong? Expected and unexpected outcomes from the usability engineering process based on real life examples - by Andrea Schütz-Frikart, Human Factor Speciailist, Frikart Engineering GmbH

Post-market surveillance, Transition from MDD to MDR

The lean and mean approach to performing MDR post-market surveillance using a realistic framework - by Stephanie Grassmann, MedTechXperts GmbH

Modular Design Control Documentation

Can Design Control Documentation be modularized and re-used in several Medical Devices? Discover the Pros and Cons - by Karl Larsson, Design Control Documentation Expert, Aligned AG

 


Time and Place

  • Date: Thursday May 17th
  • Time: 08:15 - 13:00
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.

Registration

We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

 

 


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

 

HWSMap

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

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.

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. 

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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.

qadvislogo

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!

 

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