--- title: Product Development and Compliance Blog | Cognition | Risk description: Risk | 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/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices) [FDA](https://blog.cognition.us/topic/fda) | [Product Development](https://blog.cognition.us/topic/product-development) | [Risk](https://blog.cognition.us/topic/risk) | [Industry Updates](https://blog.cognition.us/topic/industry-updates) | [Risk Management](https://blog.cognition.us/topic/risk-management) | [Webinar](https://blog.cognition.us/topic/webinar) | [Compass MED](https://blog.cognition.us/topic/compass-med) ## [Webinar On Demand: Designing for Safety - How to Build Safer, More Usable Medical Devices](https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices) By: [Cognition Corporation](https://blog.cognition.us/author/cognition-corporation) August 14th, 2025 Medical devices are becoming more complex, more connected, and increasingly used in home settings by people with varying levels of technical skill. Designing for safety isn’t just good practice—it’s a regulatory and ethical imperative. [Read More](https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices) - [**](https://twitter.com/intent/tweet?text=Webinar+On+Demand%3A+Designing+for+Safety+-+How+to+Build+Safer%2C+More+Usable+Medical+Devices&url=https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices&via=cognitioncorp) - [**](https://plus.google.com/share?url=https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices&title=Webinar+On+Demand%3A+Designing+for+Safety+-+How+to+Build+Safer%2C+More+Usable+Medical+Devices&summary=The+webinar+titled+%22Designing+for+Safety%3A+How+to+Build+Safer%2C+More+Usable+Medical+Devices%22+was+hosted+by+Rook+Quality+Systems%2C+featuring+Kyle+Rose+with+guest+speaker+Ben+Higgitt+from+Cognition+Corporation.+The+session+focused+on+integrating+risk+management+and+usability+engineering+into+the+medical+device+design+process+to+enhance+safety+and+usability.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/Copy%20of%20Copy%20of%20LIVE%20WEBINAR.png&description=The+webinar+titled+%22Designing+for+Safety%3A+How+to+Build+Safer%2C+More+Usable+Medical+Devices%22+was+hosted+by+Rook+Quality+Systems%2C+featuring+Kyle+Rose+with+guest+speaker+Ben+Higgitt+from+Cognition+Corporation.+The+session+focused+on+integrating+risk+management+and+usability+engineering+into+the+medical+device+design+process+to+enhance+safety+and+usability.) - [**](mailto:?body=https://blog.cognition.us/webinar-on-demand-designing-for-safety-how-to-build-safer-more-usable-medical-devices) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Product Development](https://blog.cognition.us/topic/product-development) | [Risk](https://blog.cognition.us/topic/risk) | [Risk Management](https://blog.cognition.us/topic/risk-management) ## [Three Key Questions for Assessing Medical Device Risk Management Tools](https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools) By: [David M. Cronin](https://blog.cognition.us/author/david-cronin) September 28th, 2021 In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge onus on design, development, and manufacturing teams. That’s why companies, large and small, are looking for software solutions to help ensure consistency and objectivity in the creation, auditing, and monitoring of critical risk management processes. [Read More](https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools) - [**](https://twitter.com/intent/tweet?text=Three+Key+Questions+for+Assessing+Medical+Device+Risk+Management+Tools&url=https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools&title=Three+Key+Questions+for+Assessing+Medical+Device+Risk+Management+Tools&summary=Companies+need+software+to+help+ensure+consistency+and+objectivity+in+the+creation%2C+auditing%2C+and+monitoring+of+critical+risk+management+processes.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools&media=https://f.hubspotusercontent00.net/hubfs/250507/Risk-management.jpg&description=Companies+need+software+to+help+ensure+consistency+and+objectivity+in+the+creation%2C+auditing%2C+and+monitoring+of+critical+risk+management+processes.) - [**](mailto:?body=https://blog.cognition.us/three-key-questions-for-assessing-medical-device-risk-management-tools) ![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/managing-risk-in-development) [design controls](https://blog.cognition.us/topic/design-controls) | [Medical Device](https://blog.cognition.us/topic/medical-device) | [Product Development](https://blog.cognition.us/topic/product-development) | [Risk](https://blog.cognition.us/topic/risk) | [Risk Management](https://blog.cognition.us/topic/risk-management) ## [Beyond Excel, Managing Risk in Medical Device Development](https://blog.cognition.us/managing-risk-in-development) By: [David M. Cronin](https://blog.cognition.us/author/david-cronin) August 17th, 2021 Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel... [Read More](https://blog.cognition.us/managing-risk-in-development) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/managing-risk-in-development) - [**](https://twitter.com/intent/tweet?text=Beyond+Excel%2C+Managing+Risk+in+Medical+Device+Development&url=https://blog.cognition.us/managing-risk-in-development&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/managing-risk-in-development) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/managing-risk-in-development&title=Beyond+Excel%2C+Managing+Risk+in+Medical+Device+Development&summary=Managing+hundreds+to+thousands+of+inter-related+data+items+manually+is+nearly+impossible+when+using+tools+like+Word+and+Excel...) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/managing-risk-in-development&media=https://f.hubspotusercontent00.net/hubfs/250507/mika-baumeister-Wpnoqo2plFA-unsplash.jpg&description=Managing+hundreds+to+thousands+of+inter-related+data+items+manually+is+nearly+impossible+when+using+tools+like+Word+and+Excel...) - [**](mailto:?body=https://blog.cognition.us/managing-risk-in-development) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/complying-with-iso-14971) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Risk](https://blog.cognition.us/topic/risk) | [Risk Management](https://blog.cognition.us/topic/risk-management) ## [Complying with ISO 14971:2019](https://blog.cognition.us/complying-with-iso-14971) By: [Ben Higgitt](https://blog.cognition.us/author/ben-higgitt) August 11th, 2020 SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks. 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