Question

Perform research (1 page) into current biomedical engineering practices to ensure best practices during the design process of this device. (180 points) (Complete 3 of the following. 60 points each) Content (65%) o Biocompatibility • What does it mean to be biocompatible? - What testing is undergone to demonstrate biocompatibility? - How do we ensure biocompatibility in humans? O FDA Regulations Process What is the role of the FDA in relation to medical devices? . What is the process for getting a new medical device approved by the FDA? • How does the FDA classify medical devices? o Medical Device Testing Techniques . What are the different levels of biological testing? . How do we replicated in vivo conditions when not performing biological testing . What are ethical concerns involved with medical device testing? o Mitigating Immune Responses . How does the body react to medical implants? • What factors determine the degree of immune response to medical implants? • What material processing is performed to reduce the immune response

please select any of the topic except FDA and biocompatibility and write 1 page essay on that including the answers of the questions given. the essay should be cited from reputable source like book, educational organization, government agency. citations is must please

Answer 1

Hemocampa tibity I Hemo compatibility is related to biocompatibility as Hemocompatibility is a kind of measure of the thrombotic response induced by a material or device in contact with blood that will lead to on of the blood coagulation The Primary goal when evaluating hemocompatibility Tas biomaterials e should be for improving the blood and tissue compatibity of the heart that has beon implanted. It should not have the allergic responses. The ability is to perform the mechanism as defends not only on its interaction with tissue but also on the intrinsic mechanical and physical properties of the materials. Sensitization reactions to biomateriau are usually associated with a brolonged or repeated contact with a cheniche substance. On the activated platelets, many different clotting factors work together in a series of complex chemical reaction to form a Chot. Coagulation factors circulate in the blood in an inactive form.