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106 results:
Market Access Europe  
Product approval Europe A wisely chosen regulatory strategy helps to get the product through "approval" and thus onto the market with minimal costs and as quickly as possible. The Johner…  
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Market Access  
Approval   No matter what product or country you need a market permit for. The Johner Institute will help you get what you need. Product approval in Europe We can help with regulatory…  
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MDR / IVDR Consulting  
How we can help you to implement the MDR or IVDR specifically for your products You now have two options: We agree an appointment for a free 15-minute strategy discussion, after which we will…  
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Data donation for research  
Help improve the regulatory system Please help improve the regulatory system! 1. Summary The regulatory system in Europe needs to be improved to ensure the provision of affordable medical…  
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Content Technical Documentation  
Content Technical Documentation What documents you need The list of documents you need depends on: the country in which you want to market your medical device the type of device (e.g.,…  
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Human Factors / Usability (IEC 62366 and FDA)  
Challenges About 70% of all software-related FDA recalls are due to lack of usability. As a result, laws in Europe and the U.S. require that you identify and manage the risks posed by your…  
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Electrical Safety & IEC 60601  
IEC 60601-compliant documentation: Electrical safety, EMC, basic safety We ensure that you develop your product quickly and in compliance with the requirements of the IEC 60601 family and pass…  
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Product Test / Evaluation  
Product test Biocompatibility test The Johner Institute helps you fulfill your legal obligation: to prove that your products are biocompatible and compliant with the relevant regulatory…  
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Biological safety  
Biocompatibility compliant with ISO 10993 Prove the biocompatibility of medical devices quickly, inexpensively and without animal testing The Johner Institute helps you fulfill your legal…  
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Computer System Validation: Avoid trouble!  
Computer System Validation: Avoid trouble with the FDA and the auditor Validation of computer systems is required by law and is checked during FDA inspections and QM audits. We will help you to…  
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