Johner Institut
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We leave nothing to chance. We have the experience, the templates, and the experts to get your medical devices through the approval process quickly and safely.
Avoid unnecessary coordination, detours, redundant work, and efforts to eliminate errors you notice too late. That will save you hassle, time, and money.
We ensure that you have all the required documentation for your target markets and that it meets the market-specific requirements.
Our more than 100 experts are also available to help you create other documents, e.g., for the risk management or usability file.
Our experienced experts are not only competent but also friendly. They make working together easy and productive.
We ensure that your medical devices are not only safe but also successful in the market.
Do you need a complete biocomp file in accordance with ISO 18562, ISO 10993, or FDA requirements for approval or an upcoming audit? We have the know-how and the proper templates!
Our expert team helps you reprocess your medical devices according to the law – from planning and laboratory selection to the final documentation.
Contact us now to discuss how we can help you demonstrate the biological safety of your medical devices.
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+49 7531 94500 20
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