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.

Focus 1: Creating FDA and IEC 62366 compliant usability files

What we can do for you

Our team of experienced usability experts (including editors for the ISO 9241 series, members of the IEC 62366 standards committee, auditors) will help you,

• Create the complete usability file.
• Review your existing documents and develop suggestions for improvement.
• With templates, which we create as examples and which you then "only" have to fill in specifically for your product.

In just a few days you will have an IEC 62366-1 and FDA-compliant usability file. 

How we can start together

Get in contact with us. We will then exchange information and, if necessary, documents. On the basis of these documents we will tell you within a short time what you have to do to document your medical device in compliance with standards and FDA requirements within a short time, so that you can shine in the audit and approval.

Focus 2: Creating Stakeholder and User Requirements, and Use Specifications

What we can do for you

We help you through a systematic requirements engineering to

• identify the actual user- and stakeholder requirements. This will be your corporate treasure, which you cannot discover by direct inquiry.
• create a list of all core tasks and main operating functions in their respective context, so that you become aware of the full potential of your medical device.
• create use specifications that takes the exact context of use into account.

Our method

Context analysis: Usability experts analyze the use context by conducting professional interviews and observations with potential users in the real user environment.

How we can get started

We are there for you when you need more than "just" legally compliant usability documentation. It is best to involve us in the development process at an early stage so that we can provide the input you need right from the start.

Contact us so that we can help you develop medical devices that will revolutionize your market.

Focus 3: Planning and conducting formative and summative human factors testing

Both the FDA and IEC 62366-1 require formative and summative usability evaluations. 

What we can do for you

We create FDA- and IEC 62366-1-compliant test plans for you and with you for both formative and summative evaluation and carry them out.

 For this

• We select the appropriate evaluation methods specifically for your product and its risks, e.g. heuristic evaluation, participating observation (usability test),
• Determine the necessary number of test persons and recruit them,
• Define the success criteria and
• Decide how the results are evaluated and documented. 

We carry out formative tests with these methods, among others:

• Heuristic evaluation: Usability experts test the product against heuristics and standards.
• Cognitive walkthrough: Usability experts guide representative users through the product to get feedback from the user.
• Usability Test: see Focus 4

How we can start

We are there for you when you need more than "just" legally compliant documentation. We always plan and design your test activities in line with the latest project status. You tell us where you stand in the development process and we plan the necessary activities for you.

Contact us so that we can help you develop medical devices that will revolutionize your market.

Focus 4: Performing usability tests for formative and summative evaluations

The German and US-American team at the Johner Institute can carry out the complete usability evaluation for you with the help of usability tests.

What we can do for you

• Human factors Testing - formative: Selected representative users test a prototype or a user interface version with any development status (low/high fidelity). Usability experts observe the completion of tasks in order to identify use errors and problems during use.
• Human factors Testing - summative: Representative users test the final product under realistic conditions. Usability experts observe the completion of tasks in order to identify use errors in hazard-related scenarios and check compliance with acceptance criteria.

How we can start

We are happy to be there for you when you need more than "just" an alibi execution during testing. We coordinate the testing effort according to the place of approval (e.g. USA or Europe) and dimension it. So you always have the most cost-effective variant.

Contact us so that we can help you develop medical devices that will revolutionize your market.

Focus 5: Managing projects

Upon request, we will support you in project management so that you can complete the usability evaluation at the planned cost within the planned time.

What we can do for you

A typical project contains the following steps:

• Review existing documentation, in particular the intended use, risk management and usability file.
• Perform gap analysis, estimate effort.
• Plan, carry out and document formative evaluation. If necessary, make suggestions for improving the user interface.
• Drawing up evaluation plans for formative and summative evaluation.
• Recruit users.
• Perform and evaluate usability tests (in the Usability Lab or in a real environment)
• Compiling usability files for the respective legal area (e.g. FDA, EU).

How we can start

We are happy to help you initiate and carry out your project activities in the most efficient and coordinated way possible. We look where there is still a need and then select the activities that are right for your project. In doing so, we pay attention to effective and efficient implementation.

Contact us so that we can help you develop medical devices that will revolutionize your market.

You can call us +1 (301) 244 6335 or write us an Email to mail@johner-institute.com, visit us or use the button below.