Usability managers at medical device and IVD manufacturers are under a lot of pressure. They must fully comply with the complex regulations in their usability files, or there is a risk of trouble in audits and reviews.
That is not only unpleasant but also expensive for the company. Especially if the device has to be improved or approval is delayed as a result. Not to mention patients who can be harmed by usability problems.
There is no need to sweat when it comes to file audits – with our experts, you are well-prepared for every audit and review.
No matter where your company wants to sell devices, we will ensure that your usability files are accepted worldwide. And when it matters, such as at FDA pre-submission meetings, our team is at your side.
With our experts, the creation of your usability file becomes a sprint. You will impress with quick outputs, and your company with devices that are quickly successful on the market.
Our medical device experts know all the rules like the back of their hands. They even sit at the table when new standards are written and, therefore, know exactly how to do everything right.
Our more than 100 experts can also help you create other documents as part of the technical documentation, such as the risk management file.
You benefit from templates that have proven themselves countless times in audits and reviews. That puts you on the safe side and saves you time and money.
Our usability experts help you with all tasks relating to your usability file:
They write your complete usability file or parts of it.
They create templates you "only" need to fill out specifically for your device.
They check your existing documents for conformity with standards, guidelines, and laws and give you targeted suggestions for improvement.
They work with you to submit your documents to notified bodies and authorities.
They prepare you for FDA pre-submission meetings and accompany you to them.
Get in touch to discuss how you can achieve legally compliant usability files as quickly and easily as possible.
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+49 7531 94500 20
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Still need to perform usability evaluations? We would be happy to support you, e.g., with your formative or summative evaluation, or make our usability lab available to you.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
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