I am doing the pacemaker

BMEN 4312 - FDA Regulations and Quality Control of Biomedical Systems Fall 2020 Homework No. 2 Due: Before the Class on Thursday, Oct. 8. 2020 Name: Total points: 100 1) Select one of the following three medical devices or your own device / biomedical system for the senior design project: a. Pacemaker: A pacemaker is a small device with two parts a generator and wires (leads, or electrodes) that's placed under the skin in patient's chest to help control the heartbeat b. Insulin pump: Insulin pump is a small, computerized device that some people with diabetes use to help manage their blood sugar. It delivers precise doses of rapid- acting insulin to closely match their body's needs. c. High-speed surgical drill system: It is a powered drill system that will remove soft tissue, hard tissue, bone, and biomaterials during surgical procedures. 2) Complete the trace matrix in the attached form (Excel File). 3) Submit the completed pdf file. 4) Grading: a. Describe the chosen product / system and its intended use (7 points); b. List at least three User Needs (21 points); c. List at least two Design Inputs for each User Need (24 points); d. List Design Output(s) for each Design Input (24 points); e. Identify Verification Method for each Design Output to ensure its conformance to Design Input requirements (24 points). BMEN 4312 - FDA Regulations and Quality Control of Biomedical Systems Fall 2020 Homework No. 2 Due: Before the Class on Thursday, Oct. 8. 2020 Name: Total points: 100 1) Select one of the following three medical devices or your own device / biomedical system for the senior design project: a. Pacemaker: A pacemaker is a small device with two parts a generator and wires (leads, or electrodes) that's placed under the skin in patient's chest to help control the heartbeat b. Insulin pump: Insulin pump is a small, computerized device that some people with diabetes use to help manage their blood sugar. It delivers precise doses of rapid- acting insulin to closely match their body's needs. c. High-speed surgical drill system: It is a powered drill system that will remove soft tissue, hard tissue, bone, and biomaterials during surgical procedures. 2) Complete the trace matrix in the attached form (Excel File). 3) Submit the completed pdf file. 4) Grading: a. Describe the chosen product / system and its intended use (7 points); b. List at least three User Needs (21 points); c. List at least two Design Inputs for each User Need (24 points); d. List Design Output(s) for each Design Input (24 points); e. Identify Verification Method for each Design Output to ensure its conformance to Design Input requirements (24 points)