Johner Institut
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We help medical device and IVD manufacturers and other economic operators in the medical technology industry gain access to all markets worldwide and make the right strategic decisions in regulatory affairs.
Our team helps you to quickly bring your medical and IVD medical devices to market in the EU – from the approval strategy to post-market surveillance.
We help you to bring your medical and IVD medical devices to market in the USA in just a few months using the 510(k) or De Novo Procedure.
Our team helps you to bring your medical or IVD medical devices to all markets worldwide in a planned and safe manner that meets all regulatory requirements.
We help you develop the right regulatory strategy to bring your medical devices to the desired market quickly, safely, and without unnecessary expense.
Our experts help you develop an optimal clinical strategy, so you know what to expect in the clinical evaluation.
Our experts help you develop a targeted IVD performance evaluation strategy that is optimally suited to the intended purpose of your in-vitro diagnostic medical device.
With our support, you can quickly bring your health institution and in-house IVD medical devices into compliance with the IVDR.
We provide reliable support to distributors and importers of medical devices in fulfilling their legal obligations under MDR and IVDR.
Our comprehensive regulatory evaluation provides a clear basis for buyers' and investors' investment decisions.
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