Medical Device Certificate (Graduate) | Temple University-PG电子试玩平台

Medical Device Certificate

The Medical Device Certificate PG电子试玩平台药学院的教授专注于医疗器械领域的国内和全球法规. 许多制药公司都有独立的设备部门或整个子公司，专注于医疗和诊断设备的营销, such as diagnostic instruments and kits, surgical sponges, and drug delivery devices, ranging from syringes to transdermal patches. This certificate is part of the school’s 法规事务(RA)和质量保证(QA)研究生课程 and is available online. 获得此证书不需要硕士学位.

法规事务专业人员通过探索制药和器械法规的异同，加深对器械领域的理解. 美国食品和药物管理局(FDA)对医疗器械的监管目标与对药物的监管目标相同:通过确保上市产品的风险与收益之间的平衡来保护公众健康. Some high-risk medical devices, such as sutures, contact lenses and antibiotic sensitivity disc, 在1976年立法通过扩大FDA对设备的监管权力之前，它们被视为药物. 因为医疗设备的复杂性和技术变化很大, 为了实现这一目标，一种比药物更灵活的监管方法已经发展起来.

医疗器械证书审查医疗器械行业的关键方面:法规, 在国内和全球领域的遵守和提交. 讲师是来自医疗器械部门的专家，他们通过实践研讨会进行高度互动的课程, 使学生能够将所学知识立即应用于工作场所.

Post-master’s Certificate

学生可以选择完成医疗器械硕士后课程. 课程着重于管理医疗器械领域的国内和全球法规. To apply for this 15-credit program, 申请人必须持有药学相关领域的硕士学位和生物科学学士学位, engineering, healthcare, natural sciences or related disciplines.

了解更多有关医疗仪器硕士后证书的信息.

药学院法规事务与质量保证

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA.

The School of Pharmacy

pioneered RA and QA graduate education in 1968, 开设第一个RA和QA在线学位课程，并提供最全面的RA和QA课程;
has outstanding expert faculty from industry and the U.S. 美国食品和药物管理局(FDA)，确保教授最新的发展和实践;
attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare);
安排现场课程，在晚上和周末进行互动讨论和研讨会;
has hundreds of students from across the country, facilitating great networking opportunities; and
provides individualized services to students.

证书提供坦普尔备受尊敬的RA和QA研究生课程的证书, which can be applied to the RA and QA master’s degree.

Program Format & Curriculum

《PG电子试玩平台》可以自行获得，也可以在前往医院的途中获得 Master of Science in RA and QA.

To earn the certificate, 以下五门课程必须在四年内顺利完成，总成绩为B (3).0) average.

Food and Drug Law (5592)
Regulation of Medical Devices: Submissions (5502)
Regulation of Medical Devices: Compliance (5496)
Global Medical Device Regulation (5505)

Students also complete one of the following electives.

Quality Audit (5494)
Computer Validation (5498)
Process Validation (5474)
Design Controls for Medical Devices & Combination Products (5503)
Pharmaceutical Packaging: Technology and Regulation (5541)
药品和医疗器械风险管理(5548)
Special Topics (any Special Topics course [5650] directly related to medical device issues)

It is suggested that students take Food and Drug Law before taking the other courses.

所有课程必须完成PG电子试玩平台的RA和QA研究生课程. No transfer credits from other institutions are accepted. 如果学生已经在美国认可的大学完成了相同的课程.S. graduate school, 学生可以申请RA和QA项目放弃该课程，并选修另一门经批准的选修课程. 这一要求必须以书面形式提出，并在学生攻读证书之前获得批准.

Learn more about the Medical Device Graduate Certificate.

See the curriculum.

Requirements

To be considered for the Medical Device Certificate, 候选人必须拥有认可的高等教育机构的学士学位.
考生必须正式申请并遵循申请程序.
在学生获得硕士学位之前，只能完成一个证书课程.
学生必须在四年内完成证书，课程可以在线完成. 学生必须在完成所有课程要求的一年内申请证书.
有兴趣攻读RA和QA硕士课程的学生可以将从医疗器械证书中获得的所有学分用于他们的研究生学位, 前提是他们正式申请硕士课程并被PG电子试玩平台录取 graduate school.