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From Idea to Approval -
Accelerate the development
of your Medical Devices

Minimize the Technical Documentation efforts and speed up
the time-to-market with supercharged Design Control and eQMS Management.

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Chosen by leading innovators

Quality, Compliance and Design Control Management.

We bring medical device companies the means to efficiently handle their quality, compliance and technical documentation tasks.

Design Control Management

Transform your Technical File writing

Unlock the massive potentials of Design Control-centric Technical Documentation building. Accelerate development and deliver complete, correct and consistent technical files.

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eQMS Quality Management

Quality that moves your Team forward

Automating and distributing quality tasks frees up time to focus on what matters. Continuously elevate your compliance level and stay ahead in a changing regulatory landscape.

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Where Innovation meets Quality

Develop and Document Medical Devices

For R&D Teams

AI-Driven Design Control Management that lets you focus on the real development! Generates consistent, complete and correct Technical Files with minimal effort.

Explore Aligned Elements

Manage Quality and Regulatory Compliance

For QA/RA Teams

Complete quality and regulatory tasks with ease to remain continuously compliant. Say goodbye to the nights and weekends spent prepping for audits and submissions.

Explore Aligned eQMS

Driving measurable improvements

95%

Of our customers experience an increased confidence in their Technical Documentation 

90%

Of our customers eliminated all missing traces with Aligned Elements

85%

Of our customers report high satisfaction with the Aligned solution.

74%

Of our customers experience an increased productivity with Aligned products

Accelerate your journey to CE Mark and FDA approval

Try aligned elements 30 days for free!

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We are Aligned. Are you?

Time to innovate!

We started Aligned to give you more time. Time to bring life-changing medical devices to patients.

Reducing your burden of documentation and administration to get there faster, is our sole purpose.

If you want to focus on what you do best, we are the right choice.

Only Medical Devices!

All our customers create medical devices. This is the market we know and the only one we care about.

We monitor market trends closely, building new features in anticipation of regulatory change.

If you want to stay ahead of the curve, we are the right choice.

We are here for you!

How did we get here?

By listening.

Our products keep reaching new heights through direct and continuous collaboration with our customers.

If you want a say in the making of the tools you use, we are the right choice.

News, Events and Resources

We benefitted by being able to create risk analyses for various product groups quite quickly and easily. We could now focus more on the content, and leave the form to the system.

Andrea Paulus

Customer Service, Product & QM Support

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

Christoph Karthaus

R&D 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.

Victor Steinacher

Project Manager

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

Claes Nilsson

Master System Engineer

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.

Anna Norlander

Senior Project 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!

Jaimin Patel

Regulatory Affairs Manager & Risk Manager

Comply with Medical Device Standards & Regulations

ISO 13485:2016

Our integrated eQMS and Design Control systems ensures alignment with ISO 13485 with controlled and auditable processes.

ISO 14971:2019

Built to support all steps of medical device compliant risk assessments in our highly configurable design control system. 

IEC 62304:2015

Medical Device Software development: supported and managed with our pre-defined IEC 62304 Design Control templates. 

FDA QSR 820

With Quality Mgmt and Design Control capabilities designed for FDA QSR 820, your journey to US market access begins here.

EU MDR

Kickstart your implementation for the european market with our GSPR requirement catalogue from the EU MDR Annex I.  

EU IVDR

Hit the ground running and start your compliance journey with a ready-to-go GSPR checklist from the EU IVDR Annex I.  

IEC 60601-1

Address essential electrical, mechanical, and environmental safety requirements with a system designed for IEC 60601-1.

IEC 62366:2015

Connect your Use Scenarios and interface design to risk assessments, formative and summative testing in Aligned.

FDA QSR Part 11

Our systems provide FDA QSR Part 11 compliant handling of electronic records and signatures, including audit trails & action monitoring.