Aligned AG

Short description

Spending too much time on design documentation and traceability? We can help! Develop medical devices smarter and faster with Aligned Elements.

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Posts (2)

Aligned AG October 21, 2021
Video

Find and eliminate errors in your Technical Documentations

To maximize your chances of getting a CE mark in time, the Quality of the Technical Documentation will be of crucial importance. Aligned Elements can help you find and eliminate quality errors in your Technical Documentation with less effort and in less time - Karl Larsson explains how.
Aligned AG July 3, 2019
Showcase

Reducing the Documentation Effort by 80 %

Like all medical device manufacturers, Tecan is subject to a growing number of regulations. Learn how Tecan reduced its effort by up to 80 % with a modular documentation approach.

Swiss Medtech Expo 2019

Standards, Products, Services

  • P ALM (Application Lifecycle Management)
  • P QMS Software
  • S Documentation
  • S Registration of medical devices
  • S Computer system validation

About us

Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry.

We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.

At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.

Many of our clients develop and manage medical products, regulated by norms such as the FDA QSR regulations in the USA or by the In Vitro Diagnostic Directives (IVD-D) in Europe. It is the special needs and circumstances which drive such projects that also shape our own portfolio.