--- title: Product Development and Compliance Blog | Cognition | Risk Management description: Risk Management | 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/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences) [FDA](https://blog.cognition.us/topic/fda) | [Product Development](https://blog.cognition.us/topic/product-development) | [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 BIO](https://blog.cognition.us/topic/compass-bio) | [Biopharma](https://blog.cognition.us/topic/biopharma) ## [Webinar On Demand: From Concept to Compliance - Navigating Risk and Regulatory Submissions Across the Life Sciences](https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences) By: [Cognition Corporation](https://blog.cognition.us/author/cognition-corporation) August 1st, 2025 If you missed our recent panel discussion, “From Concept to Compliance: Navigating Risk and Regulatory Submissions Across the Life Sciences,” the full recording is now available to watch on demand. [Read More](https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences) - [**](https://twitter.com/intent/tweet?text=Webinar+On+Demand%3A+From+Concept+to+Compliance+-+Navigating+Risk+and+Regulatory+Submissions+Across+the+Life+Sciences&url=https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences&via=cognitioncorp) - [**](https://plus.google.com/share?url=https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences&title=Webinar+On+Demand%3A+From+Concept+to+Compliance+-+Navigating+Risk+and+Regulatory+Submissions+Across+the+Life+Sciences&summary=Watch+our+expert+panel+discuss+how+life+sciences+teams+can+streamline+regulatory+submissions%2C+manage+risk%2C+and+improve+compliance%E2%80%94from+concept+to+approval.+Now+available+on+demand.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/Copy%20of%20LIVE%20WEBINAR%20%281%29.png&description=Watch+our+expert+panel+discuss+how+life+sciences+teams+can+streamline+regulatory+submissions%2C+manage+risk%2C+and+improve+compliance%E2%80%94from+concept+to+approval.+Now+available+on+demand.) - [**](mailto:?body=https://blog.cognition.us/webinar-on-demand-from-concept-to-compliance-navigating-risk-and-regulatory-submissions-across-the-life-sciences) ![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/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Risk Management](https://blog.cognition.us/topic/risk-management) | [Compass](https://blog.cognition.us/topic/compass) | [Design](https://blog.cognition.us/topic/design) | [compliance](https://blog.cognition.us/topic/compliance) | [Regulations](https://blog.cognition.us/topic/regulations) ## [Seven Ways Compass MED Helps Speed Time to Market for Med Device Manufacturers](https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers) By: [Ben Higgitt](https://blog.cognition.us/author/ben-higgitt) September 10th, 2024 Medical device manufacturers face significant pressures to bring safer products to market faster. However, meeting critical project milestones and launch dates on time and within budget is becoming increasingly difficult. Medical devices are becoming more complex—which makes product development more difficult. At the same time, industry standards and regulations are evolving, placing new pressures on quality, regulatory, and engineering teams. [Read More](https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers) - [**](https://twitter.com/intent/tweet?text=Seven+Ways+Compass+MED+Helps+Speed+Time+to+Market+for+Med+Device+Manufacturers&url=https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers&title=Seven+Ways+Compass+MED+Helps+Speed+Time+to+Market+for+Med+Device+Manufacturers&summary=7+ways+Compass+MED+helps+med+device+manufacturers+accelerate+time+to+market+with+flexible+workspaces%2C+risk+management%2C+and+submission-ready+documents.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/Cognition%20-%20Seven%20Ways%20Compass%20MED%20Helps%20Speed%20Time%20to%20Market%20for%20Med%20Device%20Manufacturers-1.png&description=7+ways+Compass+MED+helps+med+device+manufacturers+accelerate+time+to+market+with+flexible+workspaces%2C+risk+management%2C+and+submission-ready+documents.) - [**](mailto:?body=https://blog.cognition.us/seven-ways-compass-med-helps-speed-time-to-market-for-med-device-manufacturers) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Risk Management](https://blog.cognition.us/topic/risk-management) | [Compass](https://blog.cognition.us/topic/compass) | [Design](https://blog.cognition.us/topic/design) | [compliance](https://blog.cognition.us/topic/compliance) | [Regulations](https://blog.cognition.us/topic/regulations) ## [Panel Discussion: 3 Industry Leaders Explore How Medical Device Manufacturers Can Speed Time to Market](https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market) By: [Cognition Corporation](https://blog.cognition.us/author/cognition-corporation) August 5th, 2024 How can medical device manufacturers successfully balance the significant pressures of today’s market? On the one hand, they need to bring new devices to market quickly. On the other hand, devices are becoming much more complex, while at the same time, industry standards and regulations are continuing to evolve. During our recent webinar, three panelists—Nathan Brown, R&D Fellow at Boston Scientific; Mike Casper, System Engineer Manager at Smith & Nephew; and Eric Maas, a former Medtronic executive and founder of Six Sigma Experts—shared their perspectives on how medical device manufacturers can achieve speed to market, safely. [Read More](https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market) - [**](https://twitter.com/intent/tweet?text=Panel+Discussion%3A+3+Industry+Leaders+Explore+How+Medical+Device+Manufacturers+Can+Speed+Time+to+Market&url=https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market&via=cognitioncorp) - [**](https://plus.google.com/share?url=https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market&title=Panel+Discussion%3A+3+Industry+Leaders+Explore+How+Medical+Device+Manufacturers+Can+Speed+Time+to+Market&summary=In+our+latest+webinar%2C+3+industry+leaders+explore+how+medical+device+manufacturers+can+speed+time+to+market.+Here+are+the+highlights.+) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/Cognition%20-%20Blog%20-%20Panel%20Discussion_%203%20Industry%20Leaders%20Explore%20How%20Medical%20Device%20Manufacturers%20Can%20Speed%20Time%20to%20Market.png&description=In+our+latest+webinar%2C+3+industry+leaders+explore+how+medical+device+manufacturers+can+speed+time+to+market.+Here+are+the+highlights.+) - [**](mailto:?body=https://blog.cognition.us/panel-discussion-3-industry-leaders-explore-how-medical-device-manufacturers-can-speed-time-to-market) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Risk Management](https://blog.cognition.us/topic/risk-management) | [Compass](https://blog.cognition.us/topic/compass) | [Design](https://blog.cognition.us/topic/design) | [compliance](https://blog.cognition.us/topic/compliance) | [Regulations](https://blog.cognition.us/topic/regulations) ## [Are You Leading or Falling Behind? How Innovative Medical Device Manufacturers are Modifying Their Design Control Process](https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process) By: [Gerald Wesel](https://blog.cognition.us/author/gerald-wesel) April 22nd, 2024 Most medical device manufacturers continue to rely on manual and Word/Excel-based approaches for design control and risk management—and that’s hindering their ability to achieve critical strategic initiatives, including improving efficiency and accelerating time to market. [Read More](https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process) - [**](https://twitter.com/intent/tweet?text=Are+You+Leading+or+Falling+Behind%3F+How+Innovative+Medical+Device+Manufacturers+are+Modifying+Their+Design+Control+Process&url=https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process&title=Are+You+Leading+or+Falling+Behind%3F+How+Innovative+Medical+Device+Manufacturers+are+Modifying+Their+Design+Control+Process&summary=We+surveyed+100+medical+device+executives+and+engineers.+This+is+a+preview+into+some+of+the+findings.+Read+the+blog.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/Cognition%20-%20Blog%20-%20Are%20You%20Leading%20or%20Falling%20Behind.jpeg&description=We+surveyed+100+medical+device+executives+and+engineers.+This+is+a+preview+into+some+of+the+findings.+Read+the+blog.) - [**](mailto:?body=https://blog.cognition.us/how-innovative-medical-device-manufacturers-are-modifying-their-design-control-process) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Risk Management](https://blog.cognition.us/topic/risk-management) | [Compass](https://blog.cognition.us/topic/compass) | [Design](https://blog.cognition.us/topic/design) | [compliance](https://blog.cognition.us/topic/compliance) | [Regulations](https://blog.cognition.us/topic/regulations) ## [How to Speed Time to Market: Our CEO’s Take on Emerging Challenges and Acceleration Opportunities for Medical Device Companies](https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies) By: [Cognition Corporation](https://blog.cognition.us/author/cognition-corporation) March 19th, 2024 A Q&A With Gerald Wesel, Cognition Chairman and CEO Gerald Wesel, Cognition’s Chairman and CEO, is responsible for setting the company’s strategic direction. He is known for propelling innovative, disruptive technology companies to next level success, and has previously served in leadership roles at seven startups and four large enterprises. In this Q&A, he provides his take on how medical device development is evolving—and the persistent and emerging challenges that device companies are facing as a result. He also shares some key strategies that device company leaders should be employing to help their organizations adapt and thrive. [Read More](https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies) - [**](https://twitter.com/intent/tweet?text=How+to+Speed+Time+to+Market%3A+Our+CEO%E2%80%99s+Take+on+Emerging+Challenges+and+Acceleration+Opportunities+for+Medical+Device+Companies&url=https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies&via=cognitioncorp) - [**](https://plus.google.com/share?url=https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies&title=How+to+Speed+Time+to+Market%3A+Our+CEO%E2%80%99s+Take+on+Emerging+Challenges+and+Acceleration+Opportunities+for+Medical+Device+Companies&summary=Gerald+Wesel%2C+Cognition%E2%80%99s+CEO+provides+his+take+on+how+medical+device+development+is+evolving%E2%80%94and+the+persistent+and+emerging+challenges+that+companies+are+facing.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/Cognition%20-%20Blog%20-%20How%20to%20Speed%20Time%20to%20Market.png&description=Gerald+Wesel%2C+Cognition%E2%80%99s+CEO+provides+his+take+on+how+medical+device+development+is+evolving%E2%80%94and+the+persistent+and+emerging+challenges+that+companies+are+facing.) - [**](mailto:?body=https://blog.cognition.us/how-to-speed-time-to-market-medical-device-companies) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Risk Management](https://blog.cognition.us/topic/risk-management) | [Compass](https://blog.cognition.us/topic/compass) | [Design](https://blog.cognition.us/topic/design) | [compliance](https://blog.cognition.us/topic/compliance) | [Regulations](https://blog.cognition.us/topic/regulations) ## [How to Identify an Effective Medical Device Design Control Software Platform: 9 Key Considerations](https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process) By: [Ansgar Liening](https://blog.cognition.us/author/ansgar-liening) February 5th, 2024 Critical software functionality for every medical device development company Medical device development companies are increasingly recognizing the value of a purpose-built medical device design control software platform for delivering safer products to market faster, with less risk and less cost. Robust documentation processes, provided via an effective software platform that supports audits and more, ultimately lead to higher-quality products. [Read More](https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process) Share ** - ** Close - [**](https://www.facebook.com/sharer/sharer.php?u=https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process) - [**](https://twitter.com/intent/tweet?text=How+to+Identify+an+Effective+Medical+Device+Design+Control+Software+Platform%3A+9+Key+Considerations&url=https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process&via=) - [**](https://plus.google.com/share?url=https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process) - [**](https://www.linkedin.com/shareArticle?url=https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process&title=How+to+Identify+an+Effective+Medical+Device+Design+Control+Software+Platform%3A+9+Key+Considerations&summary=We%E2%80%99ve+identified+nine+critical+attributes+to+seek+out+in+order+to+help+your+organization+ensure+it+is+selecting+an+effective+medical+device+design+control+software+platform.++Learn+more.) - [**](https://pinterest.com/pin/create/button/?url=https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process&media=https://250507.fs1.hubspotusercontent-na1.net/hubfs/250507/Cognition%20Blog%20-%209%20Key%20Considerations%20%20%281%29.png&description=We%E2%80%99ve+identified+nine+critical+attributes+to+seek+out+in+order+to+help+your+organization+ensure+it+is+selecting+an+effective+medical+device+design+control+software+platform.++Learn+more.) - [**](mailto:?body=https://blog.cognition.us/9-capabilities-to-improve-your-medical-device-design-development-process) [![Blog Feature](https://cdn2.hubspot.net/hubfs/298890/blog-files/blog--cards-feature.png)](https://blog.cognition.us/why-many-medical-device-companies-are-in-danger-of-risk-analysis-missteps) [Medical Device](https://blog.cognition.us/topic/medical-device) | [Risk Management](https://blog.cognition.us/topic/risk-management) | [Compass](https://blog.cognition.us/topic/compass) | [Design](https://blog.cognition.us/topic/design) | [compliance](https://blog.cognition.us/topic/compliance) | [Regulations](https://blog.cognition.us/topic/regulations) ## [Rising Risk: Why Many Medical Device Companies Are In Danger of Risk Analysis Missteps](https://blog.cognition.us/why-many-medical-device-companies-are-in-danger-of-risk-analysis-missteps) By: [Ben Higgitt](https://blog.cognition.us/author/ben-higgitt) January 9th, 2024 Risk analysis is crucial for ensuring safety and efficacy, but a recent survey of 100 medical device development and quality leaders revealed that many lack confidence in their current risk analysis processes. 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The faster you can move without sacrificing safety or quality, the quicker your time to market and the sooner your impact on patient care. 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