Regulatory Affairs and Services
The graduate certificate in Regulatory Affairs & Services offers foundational courses in regulatory affairs for medical devices. This graduate certificate is designed for those working in the medical device industry who will benefit from education in medical device-related regulatory requirements. The certificate is also an efficient transition option for students seeking the MS degree in Regulatory Affairs & Services.
Courses
- MTQ628 — Design Control and Product Development
- MTQ634 — Corrective Action and Preventative Action (CAPA)
- MTQ638 — Supplier Development and Management
- RAS621 — Legal Basis for Medical Device Product Regulation
- RAS623 — Regulatory Routes to Market: 510(k)s
- RAS625 — Regulatory Routes to Market: PMA's
- RAS627 — Intl Regulatory Affairs: European Union, East Europe, Australia & Canada
- RAS631 — IDE Regulations and Clinical Trial Design
- RAS633 — Quality Systems for Regulated Industries
- RAS635 — Regulatory Affairs Compliance
- RAS655 — International Reg Affairs: Japan, Other Asia, Latin America & Middle East