Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Medical Device Certificate (Pre-Master's)
Increasingly, pharmaceutical companies and medical device companies are developing and marketing combination products that contain both a device and a drug component. Examples include 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 MRI systems (magnetic resonance imaging).
RA professionals from the pharmaceutical or device industries can open job opportunities by studying the similarities and differences in pharmaceutical and medical device regulations. The Medical Device Certificate enables students to receive specific training in the device field, receiving an overview of its domestic and global regulations. All courses provide hands-on application of regulations and quality practices.
The certificate requires completion of five courses:
- Food and Drug Law (5592)
- Regulation of Medical Devices: Submissions (5502)
- Regulation of Medical Devices: Compliance (5496)
- Global Regulation of Medical Devices (5505)
- One of the following electives: Quality Audit (5494) or Computer Validation (5498) or Process Validation (5474) or Pharmaceutical Packaging: Technology & Regulation (5541) or Design Controls for Medical Devices and Combination Products (5503) or Risk Management of Pharmaceutical and Medical Devices (5548) or only those Special Topics course focusing on medical devices (5650).
Transfer credits are not accepted towards Temple’s certificate programs.
Brochure - Medical Device Certificate
How to Receive the Certificate when you've completed the courses:
Submit the following items to the RAQA Office (hard copy only):
2. Photocopies of your undergraduate and graduate transcripts.
3. A transcript from Temple's Banner system of courses taken in the RAQA program.
4. Notice of Completion
All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.
Note: Students may obtain only one certificate before completing the MS program, except for Food RA and QA.