Standards we apply in our work

Our clients trust us to provide dependable, verifiable advice. All our work follows ISO, IEC, W3C, and other applicable standards and laws. But that is not all: even our results and usability audit reports come in ISO standard formats!

ISO 9241 Usability Engineering

The word “Usability” has been used and abused to mean different things to different people. At Factorsixty we work strictly according to ISO 9241, the world standard on usability.

CIF ISO 25062 Reporting for Usability Tests

Our usability test reports are standardized in the “Common Industry Format”, ISO 25062. We provide a manager’s report as well as a detailed developers’ report, including findings, screenshots, ISO 9241-110 violations, and guidance for resolving the problem.

ISO 9241-171 & WCAG Accessibility

Accessibility has become an essential requirement not only for users, but also from the legal point of view. We rely on ISO 9241-171 and WCAG to ensure your desktop software as well as your web apps and websites are accessible.

EN 301 549 Harmonized Accessibility Standard

With 2025 on the horizon and uncomfortably close, it is crucial for your products to comply with the European Accessibility Act. To ensure a smooth and reliable compliance with the EAA, we base our recommendations and guidance on this harmonized standard.

IES 62366 & IEC 60601-1-6 Usability for medical devices

Our experience with the development of software, hardware, and electronics allows us to smoothly support all three aspects of development for your medical device.

FDA Guidance: Human Factors & 
Usability Engineering

The US FDA requirements for medical devices are not the same as the EU. We keep both sets of requirements in mind when supporting the development of your medical device.

IEC 62304 software lifecycle for medical devices

The development of medical device software has strict lifecycle requirements. We take care to respect these requirements and integrate our work into your product development process.

ISO 14971 Risk management for medical devices

Usability mistakes are an essential contributor to risk in medical devices. We help you to avoid and resolve usability problems, as well as to  estimate and manage residual risk.

Our certifications

Our large spectrum of knowledge and experience allows us to choose the methods that are best for each specific client and case, thus giving you the highest return on your usability investment. We work closely with your managers, product developers, and support team, bringing in knowledge and efficiency that will continue long after our work is done.

Fraunhofer-certified Usability Engineers

We are certified as Usability Engineers by the Fraunhofer FIT Institute, one of the leading Usability training and certification agencies in Germany. The Fraunhofer certification is famous for its strict criteria and high professional standards.

Logo Certified Professional for Medical Software

Certified Professionals for Medical Software

MDR, MDD, ISO 13485, IEC 62366, ISO14971, ISO 9241, IEC 60601, IEC62304. Many standards need to be followed for medical products, but we know how to fulfill their requirements with the least overhead possible.

IREB Certified Requirements Engineers

Good user requirements stand at the foundation of successful product development. We have both the experience and the certification to do requirements correctly.

Scrum, Scrum-But, and a wide range of project management approaches

No matter whether you use agile, iterative, or traditional development approaches, we know them and will fit seamlessly with your team. We are not religious on any approach (but we are religious in delivering excellent quality with any of them!)

Still on the fence about usability?

Have a look at what usability can do for you. Or just call us!

Complying with the law

Germany’s law of employee protection mandates that all software used by employees must fulfill strict usability criteria, similar to the ones in ISO 9241. Avoid legal problems by improving the usability of your software.

Increasing sales

Designing your products according to usability criteria makes them friendlier, easier to use, easier to learn, and easier to love by your customers. Products look better, demo better, and sell better.

Lowering costs

Usability gives you better requirements, better work efficiency, and fewer customer problems. It saves you from expensive mistakes and saves development and maintenance costs, personnel costs, and technical support costs.

Increasing productivity

You are as productive as your tools allow you to be. By optimizing the usability of the software you have, and by paying attention to usability of the software you want to buy, you increase productivity and shorten training time.

Identifying opportunities

Usability deals with recognizing and solving problems with a product. This means we can also recognize problems and market opportunities that your competitors have not yet addressed and help you take advantage of them.

Diversifying products

Usability opens the door to a global market which expects usability as a standard feature. Usability analyses reveal opportunities and pain points in new fields and markets, enabling a successful entry with little expense.

Want to know more? Need a quote?