Aligned AG
We are Aligned. Our purpose is to assist our customers to develop innovative Medical Device in less time, using less resources.
Aligned was founded in 2006 by a team of experienced medical device developers with extensive and international background in the Life Science Industry.
Our clients are manufacturers, end-customers and sub-suppliers in the medical device industry, companies who develop and market products which are subjects to regulatory compliance such as FDA Quality Systems Regulations or the EU MDD/MDR and IVDD/IVDR.
Our goal is to enhance our customer's capabilities in how to rapidly and successfully create quality compliant medical devices through excellence in regulatory documentation.
Our Story
"There must be an easier way to document than this!"
We loved developing medical devices!
Not only was it exciting (it still is!), innovative and creative. It also felt meaningful; doing something that could benefit the health of potentially thousands of patients and users.
But then there was the documentation... It was always there – with us putting in endless hours on completing it, piling up as a vast mountain of binders. It sometimes felt like we were spending more time documenting than innovating. All we wanted to do was to develop devices and here we were, conducting frustrating, menial, repetitive documentation tasks.
We had fantastic, state-of-the-art engineering tools at our disposal, but for documentation we were stuck with Word and Excel. The resulting work was as you could expect. Auditors kept finding inconsistencies, errors and gaps and no matter how many times we reviewed our own documents, errors kept slipping through. Our confidence in our own documentation work was ailing at best.
We were convinced that there must be a better way to handle the documentation work than the way we were doing it. We were also convinced that medical device companies all over the world probably felt just the same way as we did.
In 2006, we started to work on Aligned Elements with the explicit goal to build a solution that could reduce the amount of work spent on development documentation while, at the same time, make sure that the resulting documentation was as error-free as possible.
Today, many years later, Aligned Elements has grown and expanded with the input from our customers, helping us to find smarter and better ways to reduce the documentation effort. We keep a close eye on regulatory changes and the challenges they entail and always, always ask ourselves, “how we can help our customers to become compliant with the least possible effort?”
At Aligned, we have our roots knee-deep in the everyday-life of medical device development and the documentation challenges that come with it.
Like you, we want medical device development to be about innovation. Afterall, that is where your hard-earned expertise lies, where you can bring most value and, quite frankly, what you were hired to do!
What we do
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.
We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.
