Post-Master’s Certificate in Medical Devices

Increasingly, pharmaceutical companies and medical device companies develop combination products that contain both a device and a drug component (drug-coated stents, prefilled drug delivery devices and antibiotic bone cement). Companies also market medical and diagnostic devices, through device divisions or subsidiaries (such as, in vitro diagnostic instruments and reagents, surgical sponges and magnetic resonance imaging [MRI] systems).

RA professionals from either the pharmaceutical or medical device industries can deepen their understanding of the field by studying the similarities and differences in pharmaceutical and medical device regulations.

The Medical Device Certificate enables students to receive specific training in the medical device field, familiarizing them with its domestic and global regulations. All courses provide hands-on application of regulations and quality practices.

Students who have received the M.S. in QA/RA from Temple are eligible to complete the Post-Master’s Certificate in Medical Devices. Courses taken for the completion of the M.S. degree will not be counted towards the Post-Master’s Certificate in Medical Devices. Students need to take four additional courses beyond the M.S. to receive the additional certificate in Medical Devices. Three of the courses taken must be Pharmaceutics 5496, 5502 and 5505. If one (or more) of those courses were already completed while the student was pursuing the M.S., the student may substitute other courses from the list of accepted courses below. Only the following courses may be taken towards completion of this program:

• Process Validation (Pharmaceutics 5474)
• Computer Validation (Pharmaceutics 5498)
• Quality Audit (Pharmaceutics 5494)
• Regulation of Medical Devices: Compliance (Pharmaceutics 5496)
• Regulation of Medical Devices: Submissions (Pharmaceutics 5502)
• Global Medical Device Regulation (Pharmaceutics 5505)
• Advanced Audit Workshop of Quality Systems (Pharmaceutics 5511)*
• Pharmaceutical Packaging: Technology and Regulation (Pharmaceutics 5541)
• Special Topics in QA/RA (section on medical devices taught by B. Berger OR section taught by M. Arentz) (Pharmaceutics 5650)*

Application
Post-M.S. Notice of Completion

This certificate is open to students who received their master's degrees from other schools; however, those students must complete Food and Drug Law (Pharmaceutics 5592) before taking any of the medical device courses; thus, their certificate will consist of five courses.

To be eligible, students must write a letter to the Assistant Dean indicating the courses they wish to pursue.  They must receive formal approval first before registering for any courses.

*These courses count towards the Certificate in Medical Devices only if the student already holds an M.S. in QA/RA.