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Performance evaluation of IVDs  
Performance evaluation of IVDs The performance evaluation is a central process that accompanies the entire life cycle of an in-vitro diagnostic medical device (IVD) and has numerous interfaces to o  
Instructions for Use & Training Materials  
Instructions for Use & Training Materials We assist you in the process of developing your Instructions for Use (IFU), user manual and training materials. According to the FDA, these materials a  
MDR / IVDR – “Person Responsible for Regulatory Compliance” (PRRC)  
MDR / IVDR – “Person Responsible for Regulatory Compliance” (PRRC) Both the MDR and the IVDR require a “person responsible for regulatory compliance” (PRRC). Some people also call them the “artic  
How Do You Write a Good Definition?  
How Do You Write a Good Definition? The importance of good definitions is best seen when there is a misunderstanding. In the worst case, a legal dispute, definitions determine whether there is liab  
Abbreviated 510(k) - When the abbreviation is allowed  
Abbreviated 510(k) - When the abbreviation is allowed Abbreviated 510 (k) is one of three 510(k) clearance processes offered by the FDA. This article tells you, what work you can save on ad  
World Medical Device Summit  
World Medical Device Summit 2022 The place where thought leaders come to get inspired The “Why” a) Situation Public healthcare systems are under increasing pressure. The pandemic makes these pr  
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