Comparing Medical Device Law & Regulations of Japan‚ EU and US Japan Competent Authority‚ Related Organization Population: 127 million Ministry of Health‚ Labor and Welfare( MHLW)‚ -Pharmaceutical and Food Safety Bureau‚ - Office of Medical Device Control - Office of Compliance - Pharmaceutical Affairs office of each Government Prefectures - Review and Audit by Pharmaceutical and Medical Device Agency (PMDA): about 30 specialists Registered Certification Body (RCB) :14 (JQA‚ TUV/RH , TUV/SUD‚ BSI
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Coronary artery disease (CAD) is a prominent cause of death for all ages in the United States. In general‚ there is a buildup of plaque inside the coronary arteries. CAD is described as a complex chronic inflammatory disease‚ regarded as plaque accumulation resulting in reduction of oxygen-rich blood flow to the heart (Sayols-Baixeras‚ Lluis-Ganella‚ Lucas‚ & Elosua‚ 2014). “Plaque is made up of deposits of cholesterol and other substances in the artery” (Centers for Disease Control and Prevention
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Riordan’s Competitive Advantages The research will describe which competitive advantages Riordan has in common with McDonald’s and Burger King. This study will estimate‚ which competitive strategies Riordan could use to improve innovation and sustainability of business operations both in the United States and in the global market. Research will explain why those competitive strategies were chosen and estimate how they may affect sustainability of long-term organizational performance. The examination
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For my Interventional clinical‚ I observed a right leg femoral artery stent placement. This involved the doctor making an incision into the leg to enter the femoral artery. The procedure was performed on an operating table‚ and a surgical technologist assisted the doctor. Collaborative care with radiology was incorporated in order for the doctor to ensure placement by ultrasound and X-ray. The doctor then would insert a balloon catheter to open a narrowed vessel (angioplasty) that supplies blood
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only precipitating factor was excessive cough‚ which had onset 5 weeks ago. Mr. KH has significant cardiac history of 2 Percutaneous Transluminal Coronary Angioplasty in 1991 and 1994‚ and had suffered Myocardial Infarction in 1999‚ after which a stent was placed. The review of systems did not reveal any neurological abnormalities and history of epilepsy‚ and physical examination showed regular strong pulse at 60 bpm and blood pressure of 150/90. ECG examination failed to show AV block‚ arrhythmia
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Competitive Advantages MGT 498 December 5‚ 2012 Professor Competitive Advantages This study will inform the audience‚ which competitive advantages Riordan has in common with Apple and Coca Cola. It will distinguish which competitive strategies Riordan may use to increase improvement and sustainability of organization procedures in the global market and the United States. The study will inform why certain types of competitive
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AISI316L Stainless steels (SS) are widely used in biomedical industries to produce orthopedic implants‚ screws‚ cardiovascular stents and other surgery devices because of their proper mechanical properties and corrosion resistance at low cost [1–5]. However‚ they have represented some premature damages when utilized in the body environment. This sort of steels is susceptible to pitting corrosion and release of Ni‚ Mo and Cr ions in body environment which can intensify the risk of cancer and inflammatory
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Peripheral Vascular Disease I. Definition of the disease A. Peripheral Arterial Disease 1. Atherosclerotic: a. Atheroma consisting of a core of cholesterol joined to proteins with a fibrous intravascular covering i. Gradual progression ii. Segmental progression 2. Nonatherosclerotic: a. Inflammatory and thrombotic process of arteries unrelated to atherosclerosis i. Faster progression than atherosclerotic disease II. Etiology/pathogenesis A. Atherosclerotic 1. Risk factors a. Age
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June 9‚ 2013 Name Date JW is an 86 year old man who lives at home with his wife of 31 years. He is in fair-good health. He has a history of prostate cancer‚ angina‚ and coronary artery disease. He has had 5 stents put in his heart over the last 10 year. He recovered well from the surgeries. He has always been athletic and fit. He played racquet ball and soft ball until he was 68 years old. He had his first Angina attack at 68. He had radiation seen implants
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Heart Disease in African Americans Stacy Johnson HCS 245 June 14‚ 2012 Margaret Latham Heart Disease in African Americans Heart disease‚ technically known as cardiovascular disease (CVD)‚ is the number one killer of African Americans. Cardiovascular disease is the narrowing of arteries due to the build-up of atherosclerosis‚ or plaque‚ in the walls of arteries (Heart.org). This narrowing of the blood vessels and arteries causes the blockage of oxygen and blood supply needed for proper function
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