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Guideline for AI for medical products  
The objective of this guideline is to provide medical device manufacturers and notified bodies instructions and to provide them with a concrete checklist to understand what the expectations of the…  
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New Zealand  
Location New Zealand Johner Institute New Zealand Ltd Adress: 235 High Street Christchurch, 8013 New Zealand Telefon: +64 (03) 423 3460 Mobil: +64 (0) 212 773 791 …  
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Why the Johner Institute?  
Why the Johner Institute? With us, you will flourish in an atmosphere of creativity, trust, mutual support and the pursuit of excellence. Rigid, hierarchical structures, frustrating supervisor…  
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Processing of personal data  
Processing of personal data We are pleased that you would like to apply for a job at Johner Institute. In the following, we explain how we process your personal data in the context of an…  
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Guided Clinical Evaluator  
Discover the Guided Clinical Evaluator - your solution for the autonomous creation of clinical evaluations.  
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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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