Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management.

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.

 

 

July 17 2017

What's New

In this release, we have continued to expand existing features in alignment with our customers feedback. Charts are now persistent, the Web client is getting really smooth and the powerful Test Run gets even more powerful.

Charts

Although charts have been a feature of Aligned Elements quite a while, you can now save them and integrate them in your Word reports.The Chart Designer lets you design and organize your charts and present the project's Design Control data in the most capturing way.

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Web Client Usability

We have included popovers of Document Objects when hovering on Document Object IDs in the Web Client. This gives a quick preview of the item's content without having to leave your context.

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Test Run Improvements

Test Runs have been enthusiastically received by the Aligned Elements User community. In this release, we have added new requested features, improved performance and fixed a number of bugs.

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What's Changed

  • Two new Inconsistency rules
  • Signalize suspect traces across project boundaries
  • Improved import mapping capabilities
  • Improved reliability and performance for Word Reports
  • Additional DB security options- Chapter content optionionally displayed as lists

Upgrade now

With more than 100 enhancements, fixes and improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 2 here.

June 23 2017

Performing Medical Device Cybersecurity Risk Assessments is something we Medical Device Manufacturers must get used to. And the sooner the better, During 2016 and 2017 a mounting number of health associated cybersecurity incidents have been reported. Cybersecurity breaches may well become THE main safety concern in our industry within the next few years. Increased regulation on this matter is to be expected.

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FDA has already published guidelines on its view on how medical device manufacturers ought to address cybersecurity in Medical Devices. The guidance outlines the documentation FDA expect to see in the premarket submissions as well as what is expected to be conducted for SOUPs and during postmarket activities.

At the core of this documentation lies the Cybersecurity Risk assessment. As already discussed, this type of risk assessment is slightly different to the typical Design Risk Assessment conducted during development.

To address this task, which many manufacturers will have to perform, we have developed a risk assessment template set specifically for documenting Cybersecurity risks and mitigations.

This template package is free to download and use for all Aligned Elements customers.

Are you interested in how the Cybersecurity Risk Assessment can be conducted and integrated with the rest of your Design Controls?

This email address is being protected from spambots. You need JavaScript enabled to view it. for a free demonstration!

The Aligned Elements Cybersecurity Risk Assessment package contains:

  • Risk assessment templates based on AAMI TIR 32, modelling Assets, Threats, Vulnerabilities and Risk Controls as Measures
  • More than 30 Best Practice Cybersecurity Risk Mitigations ready to use

If you are looking for a Cybersecurity Risk Assessment Word Template, you can download an example here:

Cyber Security Risk Assessment Word Template

 

May 07 2017

On May 5th, the final texts of the MDR (Regulation EU 2017/745) and the IVDR were published in the EU Official Journal

It's quite a chunk of text and if you have not yet started to update your Quality Management System, SOP:s and Technical Files, you should (seriously!) take some to to plan these actions accordingly.

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The EU MDR Annex I General Safety and Performance Requirements section corresponds to the Essential Requirements section in MDD Annex I.

If you want to check how your current Technical Files complies with these Requirements, you can download our checklist here:

MDR (EU 2017/745) Annex I General Safety and Performance Requirements Checklist

The MDR Annex I General Requirements are also available to Aligned Elements users as a free extension. This means that the MDR Annex I Requirements can be imported as Design Control into any of your Aligned Elements projects and included in the traceability. The extension corresponds to the requirements in the 37 page check list and are made readily available in your traceability in a matter of seconds!

The MDR Annex I General Requirements extension is yet another of the many available free extensions available to Aligned Elements user which helps them accelerate their medical device Design Control documentation effort. Browse through the available extensions and discover how they could accelerate your project.

The extension is available here: MDR (EU 2017/745) Annex I Extension

April 24 2017

 

Medical Devices Development - Sharpen your Skills 2017

May 30th, 2017 | Marriott Courtyard, Oerlikon

All options availableCompliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advise on how to meet trending medical device development challenges in 2017.

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

EU MDR: What really matters to manufacturers. And when.

What does the new EU MDR has in store for you? The 566 pages of the MDR contains a number of important changes for the medical device industry. Meet the challenges in time and in right order.

Hansjörg Riedwyl, CEO | ISS AG

Verification: yesterday, today & tomorrow

Test documentation takes up more than 50% of the total Design History File / Technical File. Time which could be better spent. Imagine 100% regression tests in a single day, for every release. Can it be made possible? Learn more in this session.

Tobias Müller, Managing Director | Progile GmbH

The seven sins of Clinical Evaluation Report writing

Regulatory requirements on clinical evaluation data has risen considerably during recent years. What are the best (and worst) practices in writing and updating state-of-the-art medical device CER:s?

Dr. Bruno Walter, Managing Director | Medical Minds

Digital Signatures = Quicker DHF Document Releases?

E-signatures boost document release efficiency according to business experts. Medical device development involves an awful lot of documents. So why should not everyone use e-signatures?  

Karl Larsson, Medical Device Documentation Expert | Aligned AG

 


Time and Place

  • Date: Tuesday May 30th
  • Time: 08:30 - 13:00
  • Place: Hotel Marriott Courtyard, Oerlikon 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 personel 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 10th

 


Location

Adress: Hotel Marriott Courtyard, Max-Bill-Platz 19, 8050 Zürich

 

 


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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