Medical Device Certificate 

The Medical Device Certificate in the School of Pharmacy at Temple University focuses on the domestic and global regulations governing the medical device field. Many pharmaceutical companies have separate device divisions or entire subsidiaries that focus on marketing medical and diagnostic devices, 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 regulatory affairs (RA) and quality assurance (QA) graduate program and is available online. 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. The Food and Drug Administration’s (FDA) regulation of medical devices has the same objective as its regulation of drugs: protecting public health by ensuring a balance of risk versus benefit for marketed products. Some high-risk medical devices, such as sutures, contact lenses and antibiotic sensitivity disc, were regulated as drugs before the 1976 legislation was passed extending the FDA’s regulatory authority over devices. Because medical devices 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.  

The Medical Device Certificate reviews key aspects of the medical device industry: regulation, compliance and submissions in the domestic and global realms. Instructors are experts from the medical device sector who conduct highly interactive classes with hands-on workshops, enabling students to apply their knowledge immediately to the workplace.

Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in medical devices. Coursework focuses on the domestic and global regulations governing the medical device field. To apply for this 15-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biological sciences, engineering, healthcare, natural sciences or related disciplines.

Learn more about the Post-master’s Certificate in Medical Device.

Program Format & Curriculum

The Medical Device Certificate may be earned on its own or on the way to the Master of Science in RA and QA.

To earn the certificate, the following five courses must be successfully completed within a four-year period with an overall 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) 

• Risk Management of Pharmaceutical and Medical Devices (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. 

All courses must be completed from Temple University’s RA and QA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, the student may petition the RA and 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.  

Learn more about the Medical Device Graduate Certificate. 

See the curriculum. 

Requirements 

• To be considered for the Medical Device Certificate, 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 and QA MS program may apply all credits earned from the Medical Device Certificate toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school.

Learn more about the application process.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS