Achieve quick and cost-effective approval for your device. We’ll guide you through the complete development and approval process, including an FDA and IEC 62366-compliant Usability Engineering File.

We’ll help you create a usability file without having to learn complicated regulations and conduct complex usability studies.

Our Services in Detail

Benefits of Working with the Johner Institute

Save Time & Money

• Accelerate your product development by pinpointing opportunities to improve your product, and creating a clear path to market. 
• Given our experience handling every type of project, we can precisely estimate the costs and effort necessary to make your project a success.
• Present confidently to regulatory bodies using time-tested methods and documentation.
• Utilize our templates to create documentation faster, including your usability file.

Work with Experts

• 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, ensuring that you avoid embarrassing complaints and costly rectifications. 
• Medical device 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.

Lower Stress

• Avoid stress in the audit and approval process, knowing that you are using proven documentation and expertise. 
• We handle all aspects of running usability studies, including recruitment and scheduling.
• We offer a 100% satisfaction guarantee. You pay nothing if you are not absolutely satisfied.

Risks of Ignoring Human Factors and Usability

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 quickly becomes very costly: paying for the auditor, for the revision of the file, and for lost profits if your product is not on the market. 
• Failure in marketing by dissatisfied customers: Poor usability leads to dissatisfied customers, unnecessarily high costs for support, and continuous improvements and “tweaks.” Ultimately, customers will choose products that are more usable.
• Damaged patients, compensation: In the worst case, a company doesn’t realize the risks of poor human factors until harm has occurred. This can lead to high indemnity claims and a damaged reputation, and it’s not uncommon: 70% of FDA recalls for software are due to usability issues!

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