Question

2. Perform research (1 page) into current biomedical engineer gineering 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

can you please write an essay for any one of the topic from the list? Please don't write about FDA as I have already done on that. the essay should be one full page with citations. citations should come from reputable source. please read the question topic and then write essay on the topic from the list.

Answer 1

Brocompatibility is a kind of describing 7 ubstance or the material which is compatible with living tissue. Biocombatible substance are those which donot produce a toxic or immunolog. ical response when exposed to the body or bodily fluids. When a material is selected for a medical device, biocompatibity is one of the most important factor that should be considered. Some of the matenals such as that are used in sufure matenial are able to support tissue healing without having angkind of reaction. The Biomaterials can be tested as:- 1) In vitrotest : These are the test which used to Stimulate biological reactions to matenáls when they are placed on tissues of the body 2) Implantation Test - These tests are used to assess the tog local pathological effects on the structure and function of living tissue induced by a sample of a material. Pyrogen Testing - Bacterial endotoxin contamination is used for testing adverse effects such as the teachates of materials which causes febrile response.