Learn to apply design control to ensure safe, effective medical devices that meet FDA and ISO standards.
Good design control keeps medical devices safe and on track for approval. This course covers the nine elements of design control under ISO 13485, from design verification and validation to the design history file, giving you a practical roadmap to product and business success.
Prerequisites:
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Sat, 04-10-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
| Sat, 04-17-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
| Sat, 04-24-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
| Sat, 05-01-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
| Sat, 05-08-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
| Sat, 05-15-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
| Sat, 05-22-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
| Sat, 06-05-2027 | 10:00am | 1:00pm | Live-Online | REMOTE |
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
No meeting on May 29, 2027. One "No Meeting" date TBA. To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Required Tools & Materials: QMSR Design and Development: https://www.fda.gov/media/189041/download
Students are expected to read the FDA Guidance on Design Control prior to the first class session.
|| Prerequisites:
Prerequisites / Skills Needed
