Aligned Elements Product News

November 11 2017

The IVDR (Regulation EU 2017/746), published in the EU Official Journal on May 5th, will have a significant impact on the manufacturers making IVDR products. 

IVDR EU Regulation 2017 746

The BSI Group calls the new risk classification in the IVDR  a “quantum leap” for products that could have been self-certified under the old directive to products soon needing notified body certification under the new regulation. Access to notified bodies has been  identified as a major bottleneck in the years to come.

IVD companies targeting the european market should therefore move swiftly and resolutly if they desire to stay in business. Compiling the Technical File could be one such task.

The EU IVDR 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 check list here:

IVDR (EU 2017/746) Annex I General Safety and Performance Requirements

Just like the MDR Annex I General Requirements, the IVDR Annex I counterparts are also available to Aligned Elements users as a free extension.

IVDR 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 31 page check list and are made readily available in your traceability in a matter of seconds!

Kickstarting your Technical File compilation with the IVDR Annex I General Requirements extension, available to Aligned Elements user in order to 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: IVDR (EU 2017/746) Annex I Extension

November 06 2017

What's New

Continued integration with external systems has been the theme of this release. We are glad to have incorporated GitHub tickets in our ecosystem. Operating with Linked Projects has now also become easier.

Hello, GitHub!

We are finally integrating towards the tickets of the most popular source code control system on the planet! The GitHub integration allows you to create, modify and trace towards GitHub Tickets e.g. when you are performing your Tests.

GithubBig

 

Web Client Usability

Improved linked project support as well as the display of Help Texts have been implemented in this release.

HelpText

 

Starting external processes

Via Workflows, it is now possible to start external processes, triggered by events in Aligend Elements. These external processes can be fed with Aligned Elements content for further processing.

adam

 

What's Changed

  • A new Inconsistency rule detecting obsolete traces
  • Default texts in Table attributes
  • Renaming of Files in Web Client
  • Creating Projects with templates in Azure File Storage
  • Optional automatic updates of linked traces

Upgrade now

With important fixes and a handfull improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 3 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.

workWithCharts

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.

TestRunPic

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.

Hacking

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.

 MDRJournal

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

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