The Importance of BEP and Report in Medical Devices
Medical devices play an essential role in healthcare and can have a significant impact on patient health and safety. To ensure the safety and effectiveness of medical devices, regulatory authorities worldwide require manufacturers to conduct a risk assessment and biological safety evaluation. This evaluation process involves the creation of a Biological Evaluation Plan (BEP) and the submission of a Biological Evaluation Report (BER), also known as a Biological Risk Assessment (BRA).
Hemocompatibilty
Hemolysis (direct & indirect)CoagulationPlatelet ActivationComplement ActivationHematology