We help you create a IEC 62366-1 and FDA-compliant usability file without having to go through complicated regulations and conduct complex usability studies. In this way, you can achieve approval quickly and cost-effectively, even with the requirements of the FDA.
We guide you through the complete development and approval process. We help you to create a lean, FDA and IEC 62366 compliant documentation (Usability Engineering File).

Our Services in Detail

This is what you will achieve with our help

• You will market your product faster.
• We have developed a variety of templates for you to help you create your documentation faster. This allows you to generate sales faster and avoid wasting time.
• You will minimize the costs for the creation of the usability file.
• Because our experience allows us to concentrate our efforts on exactly what is really necessary, the costs are reduced for you. We can precisely estimate the effort and costs. This gives you planning security. In addition, we give you a 100% satisfaction guarantee. You pay nothing if you are not absolutely satisfied.
• You will accelerate your development and be successful on the market with your products.
• Market success is not a question of luck or "good design". Rather, success depends on the extent to which you allow users to complete their tasks quickly, easily and completely. We guide you through the human factors engineering process to do just that.
• Avoid stress during the audit and approval process.
• Our experts are not only auditors, but also members of the standards committees and know exactly what it takes to create an FDA and IEC 62366-1 compliant usability file. They ensure that you avoid embarrassing complaints and time-consuming and costly rectifications. This way you get your approval without stress, delays and unnecessary costs.
• Avoid usability tests and recruitment of participants.
• Use our usability labs (in USA and Germany). Avoid recruiting participants for usability tests yourself, creating usability evaluation plans, performing usability tests and documenting them in accordance with IEC 62366-1 and FDA requirements.

What you are threatened with if you make mistakes in human factors und usability engineering

Unfortunately, we observe the following problems again and again:

• No permission to market your products: The FDA and notified bodies are obliged to examine the suitability of your usability file. If the file does not conform with regulations, you will receive it back for revision. This costs you a lot of money: for the auditor, for the revision of the file and for lost profits if your product is not on the market. These feedbacks are also embarrassing and frustrating.
• Failure in marketing by dissatisfied customers: Many manufacturers ignore that their inappropriate products lead to dissatisfied customers, unnecessarily high costs for support and continuous improvements (referred to as "enhancements"). Ultimately, customers will choose products that are more usable.
• Damaged patients, compensation: Too many companies don't realize the risks of poor human factors until something bad has happened or when people have been harmed. Then it's too late: high indemnity claims and a damaged corporate image are threatened. This is no exception: 70% of FDA recalls for software are due to a lack of usability!

Don't let it get that far and contact us right away. Together we will develop your human factors engineering process with which you can quickly and cost-effectively obtain a usability file with which you can safely pass the audit and approval.