Human Factors / Usability Engineering and Usability Testing in Europe and the US
Create IEC 62366-1 and FDA-compliant usability files in no time at all. Pass FDA approval with 100% certainty. Put medical devices on the market that are so user-friendly that you are revolutionizing your market!
Human Factors / Usability Engineering and Usability Testing in Europe and the US
Create IEC 62366-1 and FDA-compliant usability files in no time at all. Pass FDA approval with 100% certainty. Put medical devices on the market that are so user-friendly that you are revolutionizing your market!
Usability evaluations
The Johner Institute plans and performs usability evaluations not only for active medical devices, but for all medical devices of Classes I to III, for non-active medical devices as well as for training courses and instructions for use.
Formative Evaluation
The FDA and IEC 62366-1 require formative and summative usability evaluations of your product. Our experience allows us to create and execute compliant test plans independently for you, or integrated within your team.
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Heuristic Evaluation
A heuristic evaluation from our usability engineering experts will identify opportunities for improvement in your device. Heuristic evaluations can be performed at any stage of development, with design concept sketches, working prototypes, or final products.
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Summative Evaluation / Validation Testing
We develop recruitment criteria, schedule participants, and carry out summative usability studies, and ...
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Stakeholder Requirements Analysis
We conduct observational studies and context analyses, identify user requirements, and analyze risks.
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Usability Labs
We conduct studies from our own labs in Germany and the US, and cooperate with partners in other countries as necessary.
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With our help, this is what you will achieve
You will get your product onto the market more quickly.
We have developed a large number of templates for you; you can use these to create your documentation more quickly. This helps you generate sales with your product faster and avoid wasting time.
You will keep the costs of producing usability engineering files to a minimum.
Your costs are reduced because we concentrate our efforts on exactly what is really necessary based on our experience. We can estimate the effort and costs precisely and agree them with you. This gives you planning security. We also give you a 100% satisfaction guarantee. If you are not completely satisfied, you won't pay a dime.
You will accelerate your development and enjoy success with your products on the market.
Market success has nothing to do with luck or a "good design". Rather, success depends on the degree to which you allow users to get their tasks done quickly, easily, and completely. We show you the Usability Engineering Process to illustrate precisely this.
Avoid stress in audit and approval.
Our experts are not only auditors, but also members of the standards committees and know exactly what matters when creating an FDA and IEC 62366-1-compliant usability file. They ensure that you avoid embarrassing complaints and time-consuming and costly rework. We help you get your approval without stress, delays and unnecessary costs.
Avoid spending time on usability tests and participant recruitment.
Make use of our usability labs (in Frankfurt and in the USA). Don't spend time recruiting participants for usability tests, creating evaluation plans, performing usability tests and creating IEC 62366-1 and FDA-compliant documentation.
The dangers you face if you make mistakes in "usability"
Unfortunately, we see the following problems over and over again:
No approval for product marketing
The notified bodies are obliged to review usability engineering files. If the files are non-compliant, they will be returned to you for revision. This costs a lot of money: for the auditor, for revising the file and for lost profits if your product does not make it to the market. Such notifications are also embarrassing and frustrating.
Marketing setbacks due to dissatisfied customers
Many manufacturers overlook the fact that unsuitable products make for dissatisfied customers and result in unnecessarily high costs for support for constant improvements (referred to as "further development"). Ultimately, customers will choose products that have better usability.
Injured patients, compensation for damages
Too many companies only recognize the risks of inadequate usability when something bad has happened, when people have been injured. By that time, it is too late: you could face high claims for damages and a reputation in tatters. It's not a rarity, either: in the case of software, 70% of FDA recalls are due to inadequate usability!
Contact us so we can help you develop medical devices that will revolutionize your market.
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