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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 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'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.

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Cybersecurity issues resulted in 465 000 St Jude pacemakers being subjected to an 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.

Although the risk is extremely low, the cost for St Jude / Abbott is significant. For a smaller firm, these ramifications can be detrimental. The long lifetime 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 Keynote at the Swiss Medtech Expo in Luzern, 19-20 September.

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

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

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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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 are 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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On 25 May 2016, the same day as the EU agreed new rules on medical devices and in vitro diagnostic medical devices, the seminar "Medical Device Development - Sharpen your Skills!" was held at the sold-out event venue Marriott Courtyard in Zürich.

The theme of the seminar "Medical Device Development in a dynamic regulatory landscape" was scrutinized in depth by Mario Gennari, Gemar SRL, former TüV auditor and special-guest brought in by the Prismond Group, who stressed the importance of undertaking a combined, timely gap analysis of the new EU regulations as well as the updated ISO 13485:2016 in order to understand, plan and execute the necessary step to comply to the new regulatory requirements. The talk was followed by a lively discussion on how to best solve practical issues entailing these regulatory changes.

Mr. Christian Steiner, from Thoratec Switzerland GmbH shared insights and lessons learned from a recent risk management audit, how to deal with potential findings, and elaborated on best practices when undertaking risk management improvements while optimizing limited resources.

Finally, the Aligned Team presented an analysis on medical device documentation aspects, the drivers behind excessive documentation work and possible solutions around it, concluding that large potential improvements can be made through tight collaboration and feedback between the party that design processes and templates and the party being required to use and fill these artefacts with content.

If you are interested in the presentations, please This email address is being protected from spambots. You need JavaScript enabled to view it..

We are looking forward to see you at the next seminar!