Medical Device Graduate Certificate Postgraduate Programme By Temple University |TopUniversities

Programme overview

Main Subject

Pharmacy and Pharmacology

Degree

Other

Study Level

Masters

Study Mode

On Campus

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.

Programme overview

Main Subject

Pharmacy and Pharmacology

Degree

Other

Study Level

Masters

Study Mode

On Campus

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.

Admission Requirements

110+
79+
6.5+
53+
  • 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.


Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a bachelor's degree from an accredited institution. While no specific major is required, most applicants should have a background in biological sciences, engineering, healthcare, natural sciences or related discipline.

Jan
Aug

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