First Pass Design Controls - Getting it Right on your First Medical Device
Please join us for a virtual program meeting!
Date and Time
When: Tuesday, April 14, 2026, 6:30 pm – 8:00 pm CDT
Where: Virtual
Agenda:
6:30 P.M. Welcome, Announcements
7:00 P.M. Presentation
7:55 P.M. Closing Notes
Registration Link
https://app.memberplanet.com/#/event/asqminnesotasection/mnasqprogrammeetingapr2026firstpassdesigncontrolsgettingitrightonyourfirstmedicaldevice
Recertification units available:
0.1 RU Meeting (Business/Networking)
0.1 RU Workshop (1 hour)
About the Presentation
If you are part of a new startup or even an insulated development team in a larger company, you probably know how daunting it can be to collect the evidence required to demonstrate to a regulatory body that design requirements have been met. The project must proceed at a sufficiently rapid pace to ensure funding, yet submissions cannot afford to languish for months or even years in regulatory review due to disorganized or missing evidence. To ensure that all design requirements are met, FDA regulations require design controls to be in place. Too often, this translates into many hours of reviews, tedious and oversized spreadsheets, and enough signatures to slow a change assessment system to a crawl. However, when implemented correctly, design controls enhance — rather than hinder — development efforts while providing the assurance needed to enter the submission process with confidence.
This presentation takes a practical look at design controls within FDA regulations and how they have been implemented across the medical device industry. It begins with the overall purpose of design controls — focusing on following the intent of the regulation — and then explores topics including design reviews, maintaining a Design History File (DHF), and managing design changes at various development phases. The session concludes with examples of design control implementations that illustrate the importance of getting this right.
About Our Speaker:
Carl McBurney, M.S., Chemistry has been employed in the pharmaceutical and medical device manufacturing industry for 11 years in various quality roles. He is currently a Principal Design Assurance Engineer at Switchback Medical and the Treasurer for the Minnesota section of ASQ.
Please register using the link below, or copy and paste the URL from the description into your browser.
