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Appointment  
Appointment Upon request, we will arrange an appoint­ment for your indivi­dual workshop. It will take place remo­tely and usually lasts around four hours.  
Preparation  
Preparation We require your initial key ques­tions and some back­ground information before the appoint­ment. If necessary, we will first determine your role(s).  
Workshop  
Workshop In the workshop, we will first dis­cuss the regula­tory require­ments for importing or making available medical devices in the European economic area.  
Discussion and Questions  
Discussion and Questions We will then clarify all remaining questions and discuss the prac­tical signifi­cance of the require­ments according to your constellation.  
Audit of the Quality Management System  
Audit of the Quality Management System We objectively evaluate your QM system as part of an audit. We will then provide you with an audit report of any non-conformities found. If necessary, we can…  
Review of the Tech­nical Documen­tation  
Review of the Tech­nical Documen­tation Our experts objecti­vely evaluate a sample of your tech­nical documen­tation. We select a suitable device based on a risk-based approach. You will receive a…  
Issue of an MDR or IVDR Readiness Certificate  
Issue of an MDR or IVDR Readiness Certificate If there are no non-conformities or only non-conformities that can be easily or quickly remedied within your quality management system and the exemplary…  
Further Support with the Application  
Further Support with the Application We can also help you select a notified body and support you in the application pro­cess. We ensure you complete the appli­cation correctly and submit it…  
Results 1451 until 1458 out of 1458
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