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 read the question and then write one page essay on any of the topic other than FDA and biocompatibility. it should be one page full and there should be citations from reputable source. citations is must. essay should be one A4 size paper full.

YES you can , but you know the length of the paper size. Please write about medical device testing techniques topic with citations. Please don't write about other topics

Answer 1

1. A. Biocompatible means tendency of material to have desirable response in the body.

B. The stages of biocompatibility testing are :-

1. In Vitro Testing Cytotoxicity Testing (ISO1993-5)

2. In Vitro Biofunctionality Testing

3. In Vivo Biocompatibility and Biofunctionality

2. A. The FDA follows ISO 10993 standards as well as other guidelines in order protect humans and serve as a framework for selecting tests to evaluate biological response.

B. The process for getting a new medical device approval by the FDA are :-

- pre clinical

- clinical studies /trials

- NDA filed and FDA review

- post approcal risk assessment

C. Medical devices can be classified into three separate classes: class I, class II, and class III.

Class I medical devices are considered to be minimally invasive and do not contact the user internally (e.g. crutches and bedpans).

Class II medical devices have a higher degree of invasiveness and risk but relatively short duration (e.g. hearing aids and blood pumps).

Class III devices are considerably more invasive and can pose immense risk to the user-implants (e.g. cardiac pacemakers and heart valves).