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Learning Objectives   
Learning Objectives  After the seminar, you will be able to:  define comprehensible risk acceptance criteria.  systematically identify hazards and assess risks.  define suitable measures for…  
Target Group   
Target Group  This seminar is designed for people who will (in the future) take on one or more of the following roles:  Risk Manager  Quality and Regulatory Affairs Manager  Product Manager and…  
Scope of the Project  
Scope of the Project We collect the neces­sary infor­ma­tion about the system under test (SUT) and select the appropriate test cases for your device.  
Conducting a Pen Test and Presen­ting the Results  
Conducting a Pen Test and Presen­ting the Results We test your device according to the applicable require­ments of the autho­rities, such as the BSI or FDA, and follow established guides and…  
Fixing Vulnerabilities and Conducting Re-Pentest  
Fixing Vulnerabilities and Conducting Re-Pentest We work with you to define mea­sures to close the identified security gaps and improve your devices. We retest after device improvement to verify that…  
Final Report for your Cybersecurity File  
Final Report for your Cybersecurity File You will receive a final report descri­bing the test procedure in accor­dance with internationally recog­nized standards and confirming that there are no…  
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.  
Results 1441 until 1450 out of 1458
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