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2026 Episode Transcript 🇩🇪 German 🇬🇧 English …  
Feedback of our Customers: Alexa Tulaszewski, Telos GmbH  
Alexa Tulaszewski, Telos GmbH We always receive very quick and competent feedback from the Johner Institute. The offers are individually tailored to our problems and we can rely 100% on the work and…  
Feedback of our Customers: Dr. Sarah M., Regulatory Affairs Manager  
Dr. Sarah M., Regulatory Affairs Manager The starter kit provided exactly the guidance we needed. We had our clinical evaluation plan ready in two weeks!  
Feedback of our Customers: Sigmar Hengge, HeVaTech GmbH  
Sigmar Hengge, HeVaTech GmbH HeVaTech GmbH has been working with the Johner Institute for several years. Together, we have created the CER and all technical documen­tation for our medical devices.…  
Is the Starter-Kit really free?  
Is the Starter-Kit really free? Yes, 100% free of charge and without obligation.  
For which medical device classes is it suitable?  
For which medical device classes is it suitable? The starter kit is relevant for all medical device classes, with a special focus on classes IIa and IIb.  
How up-to-date is the information?  
How up-to-date is the information? As of February 2025, regularly updated in accordance with MDR changes.  
Home  
We at the Johner Institute help you overcome regulatory challenges and bring safe medical devices to market faster.  
US Market Entry Compass  
Your quick start to the launch of medical and IVD medical devices in the US market.  
Clinical Evaluation Starter-Kit  
The free Clinical Evaluation Starter-Kit includes the following: 1. Guide to the most important steps You will receive a clear roadmap from planning to the finished Clinical Evaluation…  
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