ASQ: Program Meeting – First Pass Design Controls

If you’re part of a new startup or 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.

FDA regulations require design controls to help ensure this, which can translate into many hours of reviews, oversized spreadsheets, and enough signatures to slow a change assessment system to a crawl.

But 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’ve been implemented across the medical device industry. And you’ll earn 0.2 RU’s (Recertification Units)!