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Quality Assurance for Medical Software Solutions

Software has become an integral part of medical devices and the medical device industry has high standards for quality and safety. Ensure your devices meet the strict requirements and do what they do best: Save lives.

Let us know how we can help you, help others. Get in touch with our experts and to schedule a meeting or request a demo.


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Saving Lives with High-quality Medical Software Solutions

The medical sector has always had one goal: Improving the lives of people. While this goal throughout history has never changed, the means to do so have - drastically. In today's world, software is an integral part of medical devices and there are few other industries where ensuring the software works as intended is - literally - vital. 

Therefore, the medical device industry has some of the strictest standards and guidelines (e.g IEC 62304) which need to be met. At the same time you need to make sure your software can easily be adapted to new requirements. Our analysis and testing tools help you do both.

 

 


Keep Your Software Alive with Architecture Verification

Medical devices can have long product life-cycles and will require software updates and new features to ensure that they always meet the high standards. This can be achieved best by understanding your software architecture and knowing how changes will affect your software. 

Software Architects, project leaders and developers can all benefit from knowing how the various components of a software interact with each other. You could compare this in-depth understanding of your code with a patient's anamnesis: it allows you to make informed decisions and ensures better code quality. 

Our architecture verification tool not only helps you visualize your software, it also performs automated verification checks, which immediately flag if modifications to the code deviate from the software architecture. This can be especially important if you want to make sure the changes do not violate security related attributes you defined in the architecture.

Learn more about Architecture Verification

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Automated Software Check-ups Catch Issues at an Early Stage

In medicine, the earlier a disease is diagnosed, the better it can be treated. The same is true for your software. The earlier you find bugs and identify violations of coding guidelines or regulations, the easier and cheaper it is to fix these issues and avoid them causing further damage - technical debt or software erosion - in your code.

By performing daily, automated code health check-ups you can ensure your code remains maintainable and secure. It also leads to better results during testing as potential runtime errors have already been resolved. So you not only have have high-quality code and can confirm that you comply with industry standards, you also reduce your development costs and increase your ROI.

Learn more about Static Code Analysis  

 

A Complete and Reliable Diagnosis for Your Code Health

An holistic approach ensures you have looked at all potential threats to you code's health. Only if you can confirm that you have covered your entire code, you can be sure that you have run all the tests needed.

Especially when developing for multi-platform use cases, you want to optimize and improve the efficiency of your testing protocols. When software becomes too complex, the number of input parameters and edge cases that need to be tested become overwhelming, making the final percentage points of code coverage too difficult and time-consuming to achieve with conventional test suites based on conventional cases.

Automatic test data generation accelerates the achievement of high code coverage - especially for for safety-critical industries - by aiding in code refactoring, helping uncover potential edge cases, and speeding up the testing process.

Learn more about Coco for code coverage  

 

 

 

Ensuring Safety and Saving Lives

Your guide to software testing in the medical device industry

This guide aims to clarify the regulatory requirements, challenges and best practices in medical device software testing – and give you some tips on how to improve your testing processes.

View Software Testing Guide

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Saving Lives with a Touch of a Button

Medical devices require complex software, but have to be easy to use. This means the UI has to be unambiguous and perform reliably - even when things get hectic. Ensuring this is part of the quality assurance process. It involves screens, controls, menus, buttons, icons, and so on all being assessed as part of the graphical user interface (GUI) testing to ensure the final product performs as expected.

Automating GUI testing helps keeping up with the growing complexity of medical software devices and has become the standard as part of the agile software development processes. The advantages include shorter testing cycles, better test coverage, and discovering potential bugs in the early stages of development. By combining automated GUI testing with Behavior-Driven Development (BDD), you can easily bring together technical and business project stakeholders to create high-quality products for the medical market.

Learn more about Squish for automated GUI testing  

Compliance With Medical Standards

To be given a clean bill of health, i.e. certification, your code needs to prove it meets industry standards and regulations such as IEC 62304 or FDA guidelines. Our tools have been designed to help you do just that and your software is fit for use in safety-critical medical devices.

Tool Qualification Kits

Success Stories

Read what our customers have to say. Learn more about the benefits of integrating our Quality Assurance products into your software development process.

 

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Assured with Axivion

Fresenius Medical Care

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“Thanks to the Axivion Suite, we have the maintainability of our software under control, thereby safeguarding our long-term capacity for innovation.”

ABB HQ Zurich - Switzerland (1)
Tested with Squish

ABB

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“I can program in Python and even import my own libraries in the tests. That’s where it’s handy.”

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Assured with Axivion

Dentsply Sirona

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“The Axivion Suite provides us with vital support in ensuring our software quality. Its checks are not merely driven by existing standards, they even exceed the required level.”

Meet the Experts for Medical Software Solutions

Creating software for medical devices come with a lot of responsibility and leaves no margin for error. Our experts have years of experience and can help you create high-quality software.

Whether you want a free demo or trial, want to find out more about our Proof of Value workshops or if you just need general questions answers, we are here for you.

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Article

Acing MedTech With Regulatory Intelligence

An evolving regulatory environment has historically been a bottleneck for innovation in the MedTech industry. What problem areas and strategic methodologies do forward-thinking companies embrace to overcome this and accelerate product development?

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Why MedTech Can No Longer Afford Poor UX/UI

As medical devices become increasingly complex in how they are used and how they function, poor User Experiences (UX) driven by poorly designed, non-intuitive, archaic User Interfaces (UI) pose significant challenges. The time has come to develop reliable, intuitive, modern UI/UX that improves useability and the effectiveness of medical care without compromising patient safety.

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A Prescription for Strengthening Healthcare Against Cyberattacks

The risk of cyberattacks is more significant than ever in healthcare. From advanced detection technologies to regulatory frameworks and collaborative efforts, we look at the strategies needed to safeguard patient data and maintain the integrity of life-saving systems.

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Visit our QA Resource Center

Read more success stories, watch webinars and download documents for Squish, Coco, Test Center and Axivion.

Visit QA Resource Center

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