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Study Design  
Study Design Our experts help you determine the appropriate study design for your analytical and clinical performance studies.   
Experimental Design  
Experimental Design We help you set up the experimen­tal design for the requi­red analytical perfor­mance studies and document these in test plans that comply with regulatory requirements.    
Selection of Suitable CROs    
Selection of Suitable CROs   We can help you select a suitable contract research organization (CRO) that specializes in IVD medical devices and is familiar with the spe­ci­fic requirements.   
Submission to Authorities    
Submission to Authorities   We can help you create the clinical performance study plan (CPSP), which you can submit directly and without problems.  
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…  
Results 1341 until 1350 out of 1352
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