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Kick-start your development with Aligned Elements Extensions

Written by Karl Larsson on . Posted in Tips & Tricks.

To accelerate your development documentation process, Aligned Elements supplies a number of free downloadable extensions.

These include:

  • regulatory wizards, generating requirements, risks, and other Design Control Items based on how you apply a given regulation
  • example content, such as requirements, potential hazards, risks, and other Design Control Items
  • regulatory checklists for verifying your content towards medical device norms and regulations
  • import tools, template packs, unit testing integrators, xml transformations, and much more.

The extensions can be used in your existing projects to speed up the documentation work, to serve as inspiration, or to be used as enhanced control mechanisms.

 accelerate:Courtesy of Malene Thyssen/Wikimedia

Is your device qualified for eIFU (EU No 207/2012)?

For those considering using electronic instructions for use (eIFU) according to EU 207/2012, take a closer look at the "Electronic Instructions For Use Checklist (EU 207/2012)" that helps you finding out whether your device and its intended use makes is it qualified for the regulation.

The QA-based checklist provides objective evidence, once completed, that you have made a careful and detailed analysis of your device according to EU 207/2012.

The advantages of eIFUs are many and compelling, including:

  • Reduced costs for printing and distribution
  • Possibility to include rich media content
  • Faster distribution of critical updates
  • Reduced burden on the environment

Use this checklist to confirm that the regulation applies to your device.

If the checklist establishes that EU 207/2012 applies to your device, proceed and download the 38 predefined eIFU Requirements extracted from the EU 207/2012 and import them into your project.

Accelerating the development documentation work could not be easier!