--- title: Product Development and Compliance Blog | Cognition | Compass (2) description: Compass | Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk. (2) --- [![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) 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/quality-system-based-design-process) [design controls](https://blog.cognition.us/topic/design-controls) | [Compass](https://blog.cognition.us/topic/compass) | [21 CFR 820.30](https://blog.cognition.us/topic/21-cfr-820-30) | [EU MDR](https://blog.cognition.us/topic/eu-mdr) ## [Best Practices for a Quality System Based Design Process](https://blog.cognition.us/quality-system-based-design-process) By: [Sally Carter](https://blog.cognition.us/author/sally-carter) January 27th, 2021 Imagine developing a medical device or drug that could be claimed to work without any evidence…. [Read More](https://blog.cognition.us/quality-system-based-design-process) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/quality-system-based-design-process) - [**](https://twitter.com/intent/tweet?text=Best+Practices+for+a+Quality+System+Based+Design+Process&url=https://blog.cognition.us/quality-system-based-design-process&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/quality-system-based-design-process) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/quality-system-based-design-process&title=Best+Practices+for+a+Quality+System+Based+Design+Process&summary=Learn+about+the+best+practices+for+establishing+a+quality+system+based+design+process+within+the+medical+device+design+control+regulation+framework+set+by+the+FDA.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/quality-system-based-design-process&media=https://f.hubspotusercontent00.net/hubfs/250507/edho-pratama-T6fDN60bMWY-unsplash.jpg&description=Learn+about+the+best+practices+for+establishing+a+quality+system+based+design+process+within+the+medical+device+design+control+regulation+framework+set+by+the+FDA.) - [**](mailto:?body=https://blog.cognition.us/quality-system-based-design-process) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/comprehensive-process-medical-device-development) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Product Development](https://blog.cognition.us/topic/product-development) | [Compass](https://blog.cognition.us/topic/compass) ## [Only a Comprehensive Process Can Deliver True Quality in Medical Device Development](https://blog.cognition.us/comprehensive-process-medical-device-development) By: [Ansgar Liening](https://blog.cognition.us/author/ansgar-liening) August 27th, 2020 Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed. [Read More](https://blog.cognition.us/comprehensive-process-medical-device-development) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/comprehensive-process-medical-device-development) - [**](https://twitter.com/intent/tweet?text=Only+a+Comprehensive+Process+Delivers+Quality+Medical+Device+Development&url=https://blog.cognition.us/comprehensive-process-medical-device-development&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/comprehensive-process-medical-device-development) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/comprehensive-process-medical-device-development&title=Only+a+Comprehensive+Process+Delivers+Quality+Medical+Device+Development&summary=Often+in+medical+device+product+development%2C+functions+exist+in+silos.+Yet%2C+the+data+is+both+continuously+changing+and+highly+dependent+on+one+another.+) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/comprehensive-process-medical-device-development&media=https://f.hubspotusercontent00.net/hubfs/250507/6QuestionsDC_Image1.jpg&description=Often+in+medical+device+product+development%2C+functions+exist+in+silos.+Yet%2C+the+data+is+both+continuously+changing+and+highly+dependent+on+one+another.+) - [**](mailto:?body=https://blog.cognition.us/comprehensive-process-medical-device-development) ![How to Approach Usability Engineering & Use Error Analysis](https://blog.cognition.us/hubfs/UEA_Cover_New-1.png) #### Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management. Subscribe to the blog and get this guide for free [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/mitigate-fda-form-483-automated-solution) [design controls](https://blog.cognition.us/topic/design-controls) | [Medical Device](https://blog.cognition.us/topic/medical-device) | [Compass](https://blog.cognition.us/topic/compass) ## [Mitigate the Risk of an FDA Form 483 with an Automated Solution](https://blog.cognition.us/mitigate-fda-form-483-automated-solution) By: [Cognition Corporation](https://blog.cognition.us/author/cognition-corporation) July 27th, 2020 Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483 is often referred to as “Inspectional Observations” as it is a list of conditions or practices that indicate a potential violation of FDA requirements. The form is compiled in order of importance and is considered a snapshot of potential issues; it should not be considered all-encompassing. 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