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On Thursday this week (Thu 11th, 1:30 PM - 2:30 PM), our CEO Anders Emmerich, talks at the "Mindset Impossible?" online event about the history, trends, and patterns in the digital transformation currently sweeping the medical device industry.

You can join this zoom - event. Register and get log-in details here.

The event is hosted by Digital Chameleon, a consultancy for digital transformation in the healthcare and life science sector.

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As of April 2020, we offer Aligned Elements as a Hosted solution as a complement to our existing deployment options. It is thus now possible to deploy the Aligned Elements server On-Premise, in your own Cloud, or have it hosted by us. 

The Hosted Solution will be a welcome option for our medical device manufacturing clients that do not have or are not in a position to engage, IT infrastructure and/or IT personnel.

We host your Aligned Elements database server, web application, and system integrations in the cloud on the reliable Microsoft Azure platform, applying your unique configuration of Aligned Elements, designed to match your QMS, development process, and document templates. 

Use your standard browser to access the Aligned Elements web client and allow your team to break free from technical considerations and focus on their medical device development. Automatic maintenance and monitoring are continuously performed by our experts.

As new versions of Aligned Elements are released, each client decides on when the new versions shall be deployed. A client's solution will only be updated upon explicit request in order to deliberately move from one validated application state to another. 

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We are very thankful for the engaging participation of all medical device colleagues in this year's Sharpen Your Skills event.

Videos and Slides

Perspective of Post-Market Surveillance under MDR

Download slides here.

Presented by: Linda Ahnen, PhD, Project Associate, Medidee

When to test what and why. A true story from a developer’s perspective. 

Download slides here.

Presented by: Dr. Thomas Degen, Dozent, Institut für Medizintechnik, Hochschule Luzern

Software Development According to IEC 62304 - A Real-World Perspective

Download slides here.

Presented by: Matthias Steck, Senior Consultant SW Development & Cyber Security, ISS AG

Hit by a laser – Risk Assessments Management at Ziemer Ophthalmic Systems AG

Download slides here.

Presented by: Reto Sigrist, Project Manager, Ziemer Ophthalmic Systems AG

Are we there yet? Using KPIs to track Technical File progression

Download slides here.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

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In just a few weeks you can meet us at MedConf2020 in Munich!
If you do not want to travel that far, you can benefit from this year's Hybrid event! All participants can follow the lectures and keynotes remotely just as well as on-site!

On Thursday, October 23. 13:30 - 14:15, our Design Control Management Expert Karl Larsson will present "The hidden treasure in your Technical Documentation".

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Ripple effects of all sorts is felt on many levels throughout the industry due to the strained European MDR situation.

The bottom line is simply more work for everybody. As medical device players scramble to get compliant in time, the convoluted situation has ignited creativeness among digital solution providers. New propositions emerge on how to carry out the increased workload in the most efficient manner possible. We certainly try to be one of these providers but there are plenty of other exciting companies with fantastic ideas.

One such solution provider is MedtechVault in Switzerland, a company that launched its digitization product in 2019 to target some of the complexities that emerge out of MDR. We had the opportunity to meet with Mr. Arik Zucker, co-founder of MedtechVault, and got the chance to ask him more about MedtechVault.

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If you are interested in reducing your Med Tech documentation workload, then sign up for our Best Practices in Development Documentation workshop in Schlieren Thursday, 16 January 2020 at 14.00!

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Sharpen your Skills 2018

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

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 experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein.. 

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'ts from Niclas Granqvist, Director Apps & Electronics, Polar Electro Oy

Common Usability Engineering Pitfalls

What could possibly go wrong? Expected and unexpected outcomes from the usability engineering process based on real-life examples - by Andrea Schütz-Frikart, Human Factor Specialist, 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 are 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 seeing 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

 

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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. 

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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 usability due to their 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 the potential for improvements, both in scope and implementation details. This is something we are aware of 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.