Skip to main content

EN

  • Name: Christoph Karthaus
  • Position: R&D Manager

Thanks to the Linked projects-feature, we are able to reduce the duplication of module documentation to a minimum.

  • Name: Victor Steinacher
  • Position: Project Manager

I can sincerely recommend Aligned Elements to any Medical Device company looking for a single tool to manage requirements, specifications, risks and design reviews.

  • Name: Claes Nilsson
  • Position: Master System Engineer

Aligned Elements supports a structured way to, starting from requirements, create a traceable set of documentation through the whole lifecycle.

  • Name: Anna Norlander
  • Position: Senior Project Manager

Aligned Element have made life easy working with requirement/verification including traceability. We could easily make a structure suitable for us, for all our different products and their specifications.

  • Name: Jaimin Patel
  • Position: Regulatory Affairs Manager & Risk Manager

Amazing to see how adaptable AE is to our development process and risk management process, giving us the ability to work swiftly without any unnecessary constraints!

Getting compliant with IEC 62304 may seem daunting at first. The Aligned Elements IEC 62304 configuration has been set up to guide you through this process and has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.

Continue reading

For medical device manufacturers with limited previous experience in usability engineering, the task of implementing IEC 62366-1 might seem intimidating. However, the updated 2015 version of the standard has simplified and clarified the required process steps and tasks and Aligned Elements now features a preconfigured IEC 62366-1:2015 setup that integrates the inputs, outputs and risk relevant elements of the usability process into the oveall Design Control traceability.

Continue reading