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RAPS Convergence  
Visit Johner Institute North America at RAPS Convergence in Charlotte and get practical advice on Regulatory Affairs, Regulatory Roles, QMS, Human Factors, and Usability for your medical devices as…  
Working at the Johner Institute  
Discover our current job offers and become part of our great team at the Johner Institute. We support you in continuously developing your expertise and competencies.  
Our Locations  
Where to Find Us: The Johner Institute is Represented Internationally at Several Sites in Europe and the USA  
Regulatory Strategy  
We help you develop the right regulatory strategy so that your medical devices can be approved quickly and safely in the desired market.  
Clinical Evaluation  
We offer flexible support tailored to your needs to help you achieve your clinical evaluation: compliant, comprehensive and solution-oriented.  
Guided Clinical Evaluator  
Discover the Guided Clinical Evaluator – your solution for the autonomous creation of clinical evaluations.  
What documents and information are required beforehand?  
What documents and information are required beforehand? For our workshops and strategies, we need documents such as a product description, information on how the product works, promotional…  
How do I obtain a valid approval?  
How do I obtain a valid approval? Let's schedule a brief, no-obligation initial consultation to determine which model best suits your current situation, your innovative idea, and your business goals.  
Who should participate in the workshops on behalf of the manufacturer?  
Who should participate in the workshops on behalf of the manufacturer? To ensure maximum success, the decision-makers responsible for the product (executive management, product management, marketing)…  
Who conducts the clinical evaluation?  
Who conducts the clinical evaluation? Your dossier will be prepared by experienced specialists who closely integrate regulatory and medical requirements.  
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