Aligned Elements
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Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management. Read more about medical device development insights in general and medical device application lifecycle management, in particular, using Aligned Elements - the medical device development ALM.
Aligned Elements
6d ago
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You wanted it, we're bringing it.
By popular request, we're introducing a bundle of UI improvements to our Aligned Elements Users.
An Upgraded Review Experience
Our popular Design Review functionality permits online collaboration during the review process. Each user enters observations and feedback at their own pace, which later can be addressed in an organized fashion.
However, the Review process may differ from company to company and hence, the Aligned Elements community reached out to us with suggestions to strengthen the Design Review further.
In Aligned Elements V3.0, w ..read more
Aligned Elements
2w ago
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One of our best known features is Aligned Elements Word Integration.
This unrivalled feature lets you compose Design Control documents by filling your Word Templates with content from Aligned Elements.
You decide which data goes where and what the data should look like. The output is tailored to your company's process, product, templates and corporate design.
This is pure flexibility and adaptability, where you are in total control of the document creation.
When Control and Speed is all you need
However, there are situations where you don't want all that flexibility, ca ..read more
Aligned Elements
3w ago
Let's be frank.
Documentation plays a crucial role in your QMS.
The efficiency of your medical device company relies on your ability to manage and control the technical documentation.
These documents, being required by ISO 13485 and FDA QSR 820, must be correct, complete, and consistent.
To achieve this, solid document control is required.
However, systems and procedures that do not support efficient and streamlined document control can make the work overwhelming. When scrambling to get the Technical File ready for release, a stream of documentation activities occurs in parallel, with multipl ..read more
Aligned Elements
1M ago
We know you want to focus on making the world's best medical devices.
Not filling out forms.
Or man-handle Excel trace tables.
Or slowly wither away in endless review meetings.
We loved creating medical devices. It's exciting, it's innovative, and it feels good to know we're helping people's health.
But, boy, the Technical Documentation...
We had top-notch tools for engineering, but when it came to documentation, we were stuck with Word and Excel.
And let's be honest, the results weren't great. Auditors kept finding mistakes, no matter how many times we checked our work.
That's why we decided ..read more
Aligned Elements
6M ago
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Thank you very much for joining us last Tuesday!
Find the recordings of the four expert sessions below. See you again next year!
Session Recordings Four things the e-STAR template teaches us about digitalization
Presented by: Thomas Bohnen, CEO, KEYMKR
Unveiling FDA's new Computer Software Assurance: What Lies Beneath the Surface!
Presented by: Peter Roka, MedTech Consultant, QUAREGIA
How to avoid Death by Documentation?
Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG ..read more
Aligned Elements
11M ago
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We are very excited about the many engaged participants joining us last Tuesday!
Aligned's Sharpen Your Skills event proves to be worth a visit once again!
Find the recordings of the four expert sessions below. See you again next year!
Session Recordings Why Medical Device Companies are Rubbish at Requirements
Presented by: Peter Sebelius, CEO and Consultant, Medical Device HQ
If everyone comes first - they all come last! Escaping the Risk PMS / Clinical Deadlock
Presented by: Stefan Bolleininger, CEO, be-on-quality GmbH
Post-Market Surveillance under MD ..read more
Aligned Elements
1y ago
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In this latest release of Aligned Elements V2.6 Service Pack 1, we tell you all about...
Search-as-you-type in the Word Add-In
Import Files in batch
User and Project Management improvements
Integration with Open AI
The webinar can be viewed below:
Enjoy ..read more
Aligned Elements
1y ago
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Tuesday May 9th, 2023 | 13:30 - 16:30 CET | Free Online Medical Device Development Seminar
Compliant and Efficient Medical Device Development
An impossible combination?
We provide concrete and practical advice on how to meet common and urgent medical device development challenges.
Meet our group of experienced industry experts to share their latest best practices on how to eliminate problems with you.
Register now to reserve your seat!
Register on Linked In: https://www.linkedin.com/events/705401801366194995 ..read more
Aligned Elements
1y ago
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In this latest release of Aligned Elements V2.6, you find great new features such as...
Trace Tables based on Snapshots
Chapter Descriptions
Traced Object Attributes
Automatic Recovery of Data
The webinar can be viewed below:
Enjoy ..read more
Aligned Elements
1y ago
There are few standards that have higher influence on the daily workday than ISO 13485. Most processes used by a Medical Device manufacturer are mentioned and regulated by this ISO standard.
If you want to check how well your organisation fulfils the ISO 13485, you can use this new Aligned Elements Extension in your Aligned Elements instance.
This checklist extension covers key clauses in the sections:
4 - Quality management system
5 - Management responsibility
6 - Resource management
7 - Product realization
8 - Measurement, analysis, and improvement
With this checklist it is easier for you ..read more