The faster way to medical devices compliance

Worldclass Design Control Management will accelerate your Technical File / Design History File completion 

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Core Features

Aligned Elements is the Medical Device ALM that helps you create, manage and trace the Design Control Items of your Design History File.

Requirements Management

Manage, review and release requirements during the entire Lifeycle. Any changes made are under strict version control with integrated change impact analysis.

ISO 14971 Risk Management

Conduct top-down (Preliminary Hazard Analysis) and bottom-up (FMEA) ISO 14971 compliant risk assessments, tightly integrated in the traceability landscape.

End to End traceability

Intuitive management of traces, combined with a clear visualization of the traceability status eliminates compliant problems and consistency issues.

Verification & Validation

Create, manage and run automated and manual test cases and monitor the progress. Seamlessly integrate with your own bug tracking systems.  

Document Management

With the industry's most powerful and flexible Word integration in your hands, digitize your Technical File / DHF document management.

Analytics and Visualization

Automatically scan and monitor your project to detect and visualize gaps and trends in the consistency and completeness of your DHF.

Develop Faster

Is your team held up by documentation work when it should innovate state-of-the-art medical devices?

Medical Device companies report that up to 30% of the total development effort is spent on documentation activities.

Unmatched Transparency

Aligned Elements integrates and traces all Design Control Items in your application lifecycle into one single application.

Eliminate manual merging and mapping across separate systems and rely on automatic consistency monitoring to drive out quality errors.

Fast track to regulatory approval

Built for Medical Device development from the ground up, industry regulations and standards are supported out-of-the-box.

Risk Assessments, Design Reviews, DHF Index and Regulatory check lists addresses the special needs of medical device development.

Accelerate your journey to CE Mark and FDA approval

Try aligned elements 30 days for free!

user story

mSafety - brought by Sony

New Customer Story

Sony's mSafety says, "Yes, you can"

Sony developed mSafety which combines a user-friendly wearable health/wellness device with a reliable back-end solution. Read more about the development of mSafety and their reasoning for choosing Aligned Elements for Design Control Management.

Medical Device Standards and Regulations

Aligned Elements capabilities helps you to stay in compliance with standards and regulations essential to medical device development.

We continously monitor the regulatory landscape to addresses your emerging compliance challenges in upcoming releases.

ISO 13485:2016

Built to fulfill design control and change requirements as defined in ISO 13485:2016.

ISO 14971:2019

Perform medical device compliant risk assessments in our highly configurable environment. 

IEC 62304:2015

Use our pre-defined IEC 62304 template set to document and develop medical device software. 

FDA QSR 820

Design control management capabilities in compliance with the Quality System Regulations (QSR).

EU MDR/IVDR

Download, import and kick-start with our pre-configured GSPRs from the EU MDR and IVDR Annex I.  

IEC 60601-1

A smoother and faster IEC 60606-1 experience with our importable IEC/ISO 60601-1 Checklist.

Why Aligned Elements accelerates your development

Reduce time spent on documentation

Is your team held up by documentation work when it should innovate state-of-the-art medical devices?

Then you are not alone.

Medical Device companies report that up to 30% of the total development effort is spent on documentation activities. By spending less time on regulatory documentation, you can free up valuable resources for innovation. 

Eliminate Design Control errors

By tracking every change, Aligned Elements provides a complete and chronological audit trail of the entire Technical File.

Automatic change control is part of the regular workflow, ensuring a smooth daily use without obstructing the normal operations.

Real-time assessments on the consistency and completeness of the DHF content uncovers any faults and gaps, well in time before the auditor does.

100% tailored to your QMS

You have built your QMS to provide maximum efficiency and compliance to your unqie situation.

Therefore, we configure Aligned Elements to each customer's unique QMS, development process and document templates to bring out all the value that has been carefully designed into your unique way of working.

We believe that Aligned Elements shall adapt to you, not the other way around.

For Medical Device Developers by Medical Device Experts

Aligned Elements is constructed with the medical device regulations in mind from ground up.

It is designed by Medical Device experts, with decades of experience from real-world medical device development.

These experts constantly update and refine Aligned Elements in response to emerging regulatory challenges with the ultimate goal to reduce your effort and increase the quality of your output.

Integrated and connected

Developing medical devices is a complex mission involving a number of engineering disciplines, organizational units and, of course, software systems.

Aligned Elements integrates into your IT landscape to leverage your existing data in your existing systems such as Jira, Azure DevOps, GitHub, Enterprise Architect and many more.

Cloud, Hosted or On-Premise

Whether On-premise, in your Cloud or as Hosted Saas, we are flexible.

You decide on the best Aligned Elements deployment option for your company.

We support you with technical assistance in all deployment cases. 

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