--- title: Product Development and Compliance Blog | Cognition | QMSR description: QMSR | Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk. --- [![Cognition Corporation Logo](https://blog.cognition.us/hs-fs/hubfs/Cognition+without+Tagline+Horizontal+Full+Color.png?width=500&height=500&name=Cognition+without+Tagline+Horizontal+Full+Color.png "Cognition Corporation Logo")](https://cognition.us/) [GET A DEMO](https://info.cognition.us/cognition-corporation-demo-request) - Categories** - Follow Us** - [Subscribe](https://info.cognition.us/subscribe-use-error-analysis-white-paper) - [**](http://www.twitter.com/cognitioncorp/) - [**](http://www.linkedin.com/company/cognition-corporation) # Medical Device and Pharmaceutical Product Development and Compliance Cognition Blog Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk. [Subscribe](https://info.cognition.us/subscribe-use-error-analysis-white-paper) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr) [FDA](https://blog.cognition.us/topic/fda) | [design controls](https://blog.cognition.us/topic/design-controls) | [Design](https://blog.cognition.us/topic/design) | [Compass MED](https://blog.cognition.us/topic/compass-med) | [QMSR](https://blog.cognition.us/topic/qmsr) ## [5 Design Control Gaps the FDA Will Target Under QMSR](https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr) By: [Sally Carter](https://blog.cognition.us/author/sally-carter) January 30th, 2026 The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, represents more than a regulatory update—it fundamentally changes how design controls are evaluated during inspections. As the FDA aligns 21 CFR 820 with ISO 13485, inspectors will move beyond checking whether design control documents exist. Instead, they will assess whether design controls function as a connected, traceable system that integrates risk management, verification, validation, and change control. Below are five design control gaps the FDA will increasingly target under QMSR, and why many medical device companies may not be prepared. [Read More](https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr) - [**](https://twitter.com/intent/tweet?text=5+Design+Control+Gaps+the+FDA+Will+Target+Under+QMSR&url=https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr&title=5+Design+Control+Gaps+the+FDA+Will+Target+Under+QMSR&summary=The+FDA%E2%80%99s+QMSR+represents+more+than+a+regulatory+update%E2%80%94it+fundamentally+changes+how+design+controls+are+evaluated+during+inspections.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/QMSR.png&description=The+FDA%E2%80%99s+QMSR+represents+more+than+a+regulatory+update%E2%80%94it+fundamentally+changes+how+design+controls+are+evaluated+during+inspections.) - [**](mailto:?body=https://blog.cognition.us/5-design-control-gaps-the-fda-will-target-under-qmsr) [ All posts ](https://blog.cognition.us/all) [![cognition logo white](https://blog.cognition.us/hubfs/Cognition-with-Tagline-White-250.png)](https://blog.cognition.us/) [info@cognition.us ](mailto:info@cognition.us) [1 (781) 271-9300](tel:1-781-271-9300) 24 Hartwell Avenue, Lexington, Massachusetts 02421 [![White LinkedIn Logo](https://blog.cognition.us/hubfs/Mahalo/social_icons/LinkedIn%20Icon%20White.png)](https://www.linkedin.com/company/cognition-corporation/) [![Twitter White Logo](https://blog.cognition.us/hubfs/Mahalo/social_icons/Twitter%20Icon%20White.png)](https://twitter.com/cognitioncorp) ©2026 Cognition Corporation | [Privacy Policy](https://cognition.us/privacy-policy/)