BIOE 5250 — Regulatory and Quality Aspects of Medical Device Design
4 semester hoursGraduateLectureusually offered: fall, springtypical days: TBostonOnlineTraditionalVideo Streaming
Covers engineering design challenges intrinsic to the development of biomedical devices, including clinical evaluation, manufacture, and testing of medical devices and the constraints that FDA regulations place on these processes. Topics include quality systems, design control, cybersecurity concerns, the role of standards in global device regulation, and the design process. Students are asked to form teams and to carry out a semester-long conceptual design project to develop a design overview, design plan, design input specifications, and verification test procedures for a novel medical device.
Offering history
| Term | Sections | Enrolled | Capacity | Full | Open seats/section |
|---|---|---|---|---|---|
| Fall 2023 | 2 | 48 | 54 | 89% | 3.0 |
| Spring 2024 | 2 | 48 | 65 | 74% | 8.5 |
| Fall 2024 | 2 | 38 | 53 | 72% | 7.5 |
| Spring 2025 | 2 | 64 | 68 | 94% | 2.0 |
| Fall 2025 | 2 | 53 | 57 | 93% | 2.0 |
| Spring 2026 | 2 | 54 | 59 | 92% | 2.5 |
Snapshots from scheduled scrapes — not live seat availability. "Full" can exceed 100% when sections over-enroll.
Meeting times
Share of recent sections by weekday: M 0% · T 95% · W 0% · Th 0% · F 0%
Common patterns: T (95% of sections), async (5% of sections) — in patterns, R means Thursday
Professors
Fall
Spring
Percentages are each professor's average share of the season's enrolled students in recent terms.
Links
Official catalog (BIOE course descriptions) · Student reviews on RateMyHusky · All BIOE courses · Plan it at numap.app