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US Agent  
We are your reliable partner for legally compliant communication with the FDA and, as your US Agent, ensure your market access in the USA.  
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Authorized Representative  
We are your reliable authorized representative for medical devices in Europe and Switzerland, as well as your Responsible Person in the United Kingdom, and your US Agent in the USA, ensuring your…  
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Post-Market Radar  
The Post-Market Radar takes over continuously monitoring the relevant notifications for your medical devices.  
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Regulatory Radar  
Always on track with the Regulatory Radar – for seamless compliance in the medical technology and pharmaceutical industry  In the medical technology and pharmaceutical industry, more…  
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Book Demo  
Book your free live demo for the Regulatory Radar now Our expert from the Johner Institute will guide you through the intuitive user interface and show you how you can use the database to…  
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Book Demo  
Book your free live demo for the Post-Market Radar now Our expert from the Johner Institute will guide you through the intuitive user interface and show you how you can use the software to…  
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Regulatory Intelligence  
Shorten your time-to-market – with Regulatory Intelligence SaaS for market leaders  The growing complexity of the regulatory environment in the medical technology and pharmaceutical industry…  
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Clinical Investigations and Studies  
We help you to achieve your market approval with lean clinical investigations.  
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Fit for Future Program  
Discover the digital future of regulatory affairs – fast approval of (IVD) medical devices and regu-latory safety with the Fit for Future Program.  
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Post-Market Surveillance, Post-Market Clinical Follow-up, Post-Market Performance Follow-up  
Fast and compliant documentation of your Post-Market Surveillance (PMS), PMCF, or PMPF, which you can submit right away.  
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