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106 results:
Person Responsible for Regulatory Compliance (PRRC)  
We take on the role of the Person Responsible for Regulatory Compliance (PRRC) according to MDR and IVDR and ensure your regulatory compliance.  
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Virtual Manufacturing / Own-brand Labeling  
Legal Manufacturer EU  Johner Institute is your legal manufacturer for medical devices in Europe Faster Market Access  Significantly shorten your time to market with our proven…  
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Quality Management Representative (QMR)  
As your experienced external quality management representative, we ensure regulatory compliance with your quality management system.  
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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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Clinical Investigations and Studies  
We help you to achieve your market approval with lean clinical investigations.  
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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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The clinical evaluation in the MDR  
Clinical Evaluation Clinical evaluations made easy: Fast and safe through approvals, audits, and reviews  Clinical affairs teams are often under great pressure: notified bodies demand…  
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Clinical Strategy  
We help you develop an optimal clinical strategy, so you know what to expect during the clinical evaluation.  
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Jobs at Johner Institute  
Dream jobs at Johner Institute Become part of our great team! Our more than 150 colleagues at the Johner Institute work hand in hand to fulfill our mission every day: We support manufacturers of…  
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