医疗器械证书 

的 医疗器械证书 in the 药学院 at 亿德体育 focuses on the domestic and global regulations governing the 医疗设备 field. Many pharmaceutical companies have separate device divisions or entire subsidiaries that focus on marketing medical and diagnostic devices, 如诊断仪器和工具包, 手术海绵, 以及给药装置, 从注射器到透皮贴剂. 这个证书是学校颁发的 regulatory affairs (RA) and quality assurance (QA) graduate program 可以在网上找到. A master’s degree is not required to earn this certificate.

Regulatory affairs professionals pursuing this certificate will deepen their understanding of the device field by exploring the similarities and differences in pharmaceutical and device regulations. 的 Food and Drug Administration’s (FDA) regulation of 医疗设备s has the same objective as its regulation of drugs: protecting public health by ensuring a balance of risk versus benefit for marketed products. 一些高风险医疗设备, 比如缝合线, 隐形眼镜和抗生素敏感盘, were regulated as drugs before the 1976 legislation was passed extending the FDA’s regulatory authority over devices. Because 医疗设备s are highly variable in complexity and technology, a more flexible approach to their regulation has evolved to meet this objective than has evolved for drugs.  

的 医疗器械证书 reviews key aspects of the 医疗设备 industry: regulation, compliance and submissions in the domestic and global realms. Instructors are experts from the 医疗设备 sector who conduct highly interactive classes with hands-on workshops, enabling students to apply their knowledge immediately to the workplace.

邮政局长的证书

Students have the option to complete a post-master’s curriculum in 医疗设备s. Coursework focuses on the domestic and global regulations governing the 医疗设备 field. 申请这个15学分的课程, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biological sciences, 工程, 医疗保健, 自然科学或相关学科.

Learn more about the 邮政局长的证书 in Medical Device.

程序的格式 & 课程

的 医疗器械证书 may be earned on its own or on the way to the RA和QA理学硕士学位.

要获得证书, the following five courses must be successfully completed within a four-year period with an overall B (3.0)平均.  

• 食品及药物法(5592) 

• 医疗仪器规管:意见书(5502) 

• 医疗仪器的规管:合规性(5496) 

• 全球医疗器械法规(5505)  

学生还要完成以下选修课之一. 

• 质量审核(5494)

• 电脑验证(5498)  

• 工艺验证(5474) 

• 医疗器械的设计控制 & 组合产品(5503) 

• Pharmaceutical Packaging: Technology and Regulation (5541) 

• Risk Management of Pharmaceutical and Medical Devices (5548) 

• 特别的主题 (任何 专题课程[5650] 与医疗器械问题直接相关)  

建议学生参加 食品及药物法 在上其他课程之前. 

All courses must be completed from 亿德体育’s RA和QA graduate program. 不接受其他院校的转学分. If a student has completed an identical course at an accredited U.S. 研究生院, the student may petition the RA和QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate.  

了解更多关于医疗器械毕业生证书的信息. 

参见课程设置. 

需求 

• 将被考虑用于医疗器械证书, candidates must have a bachelor’s degree from an accredited institution of higher learning. 

• Candidates must formally apply and follow the application procedures. 

• Only one certificate program may be completed before students receive the MS. 

• Students must complete the certificate within four years, and courses may be completed online. Students must apply for the certificate within one year of completing all required coursework for the program. 

• Students interested in pursuing the RA和QA MS program may apply all credits earned from the 医疗器械证书 toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by 亿德体育’s 研究生院.

了解更多有关申请流程的信息.

相关研究生学位

• 法规事务和质量保证硕士