--- title: LaunchWorks Manufacturing Lab is now FDA Registered for the third time! description: LaunchWorks Manufacturing Lab is an FDA Registered, ISO 13485 certified & cGMP compliant CMO partner in genomic product commercialization in Massachusetts. image: https://www.launchworkscdmo.com/hubfs/ErrorProofing.png --- [Skip to content](https://www.launchworkscdmo.com/blog/fda-registered#main-content) Close - Diagnostic Solutions - [Product Manufacturing Plan](https://www.launchworkscdmo.com/the-launchworks-process) - [Design & Development](https://www.launchworkscdmo.com/design-and-development) - [Manufacturing](https://www.launchworkscdmo.com/manufacturing) - [Fulfillment & Storage](https://www.launchworkscdmo.com/fulfillment-and-storage) - Resources - [Blog](https://www.launchworkscdmo.com/blog) - [Case Studies](https://www.launchworkscdmo.com/case-studies) - Company - [Our Mission](https://www.launchworkscdmo.com/about) - [Certifications](https://www.launchworkscdmo.com/certifications) - [Partnerships](https://www.launchworkscdmo.com/partnerships) - [Careers](https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=17f3997b-cf29-4fb6-870e-662bde99b8dd&ccId=9200188977426_2&lang=en_US) - [Contact](https://www.launchworkscdmo.com/contact-us) SEARCH [![Get Started](https://no-cache.hubspot.com/cta/default/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45.png)](https://cta-redirect.hubspot.com/cta/redirect/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45) [![LaunchWorks Manufacturing Lab](https://www.launchworkscdmo.com/hs-fs/hubfs/LaunchWorks%20logo%20and%20tag_RGB.png?width=400&height=77&name=LaunchWorks%20logo%20and%20tag_RGB.png)![LaunchWorks-logo-WHITE_w-tag](https://www.launchworkscdmo.com/hubfs/Logo/LaunchWorks-logo-WHITE_w-tag.svg)](https://www.launchworkscdmo.com) - Diagnostic Solutions - [Product Manufacturing Plan](https://www.launchworkscdmo.com/the-launchworks-process) - [Design & Development](https://www.launchworkscdmo.com/design-and-development) - [Manufacturing](https://www.launchworkscdmo.com/manufacturing) - [Fulfillment & Storage](https://www.launchworkscdmo.com/fulfillment-and-storage) - Resources - [Blog](https://www.launchworkscdmo.com/blog) - [Case Studies](https://www.launchworkscdmo.com/case-studies) - Company - [Our Mission](https://www.launchworkscdmo.com/about) - [Certifications](https://www.launchworkscdmo.com/certifications) - [Partnerships](https://www.launchworkscdmo.com/partnerships) - [Careers](https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=17f3997b-cf29-4fb6-870e-662bde99b8dd&ccId=9200188977426_2&lang=en_US) - [Contact](https://www.launchworkscdmo.com/contact-us) [![Get Started](https://no-cache.hubspot.com/cta/default/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45.png)](https://cta-redirect.hubspot.com/cta/redirect/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45) Quick results for "{search\_term}" ![](https://www.launchworkscdmo.com/hs-fs/hubfs/ErrorProofing.png?width=300&name=ErrorProofing.png) [LaunchWorks](https://www.launchworkscdmo.com/blog/author/launchworks)Aug 14, 2017 12:39:28 PM< 1 min read # LaunchWorks Manufacturing Lab is now FDA Registered, cGMP Compliant and ISO 13485:2016 Certified by TUV for the third time! [Next](https://www.launchworkscdmo.com/blog/new-laboratory-of-industrial-fluidic-translation-lift-to-develop-microfluidic-device-tests-for-the-diagnostic-market) [![FDAregisteredRocket-banner.png](https://www.launchworkscdmo.com/hs-fs/hubfs/FDAregisteredRocket-banner.png?width=638&height=407&name=FDAregisteredRocket-banner.png)](https://www.launchworkscdmo.com/fda-registration) **So what’s that do for a startup biotech or new life science product launch you ask?  Good question!  Here is the short answer for you;** [Our FDA Registration](https://www.launchworkscdmo.com/fda-registration) will give our customers increased traceability to the FDA by registering LaunchWorks Manufacturing Lab as their manufacturing partner. cGMP Compliance provides our customers added assurance that we follow FDA cGMP Compliance for medical devices. Being [ISO 13485:2016 Certified](https://www.launchworkscdmo.com/launchworks-manufacturing-lab-a-life-science-cmo-iso-13485-certificate-download) allows our customers to gain confidence that we have been audited by a third party and that we follow all the applicable regulations under the scope of our ISO certification If you would like to know more about these quality assurance claim’s please review the links in this post to the related documentation. Our QA team is available to answer questions through our [“Contact Us”](https://www.launchworkscdmo.com/contactus) form as well.   [LaunchWorks](https://www.launchworkscdmo.com/blog/author/launchworks)LaunchWorks is a winning team of innovative, experienced, and knowledgeable contract manufacturing experts with a track record of turning complex life science ideas into high-quality products on-time and on-budget. COMMENTS ## RELATED ARTICLES [![LaunchWorks-logo-WHITE_w-tag](https://2359995.fs1.hubspotusercontent-na1.net/hubfs/2359995/Logo/LaunchWorks-logo-WHITE_w-tag.svg)](https://www.launchworkscdmo.com) Advance your life sciences products for optimized results, no matter the production stage. As a full-service ISO-13485:2016 and FDA registered certified contract manufacturer, LaunchWorks CDMO’s mission is to help you focus on your science. All rights reserved - [Terms and Conditions](https://www.launchworkscdmo.com/launchworks-terms-and-conditions) - [Customer Fulfillment Portal](https://launchworks.lp4fb.com/index.php?route=account/login) - [Contact](https://www.launchworkscdmo.com/contact-us) ```json { "@context" : "https://schema.org", "@type" : "Organization", "address" : { "@type" : "PostalAddress", "addressCountry" : "USA", "addressLocality" : "Beverly", "addressRegion" : "MA", "postalCode" : "01915", "streetAddress" : "123 Brimbal Avenue" }, "knowsLanguage" : "en-us", "logo" : { "@type" : "ImageObject", "url" : "https://cdn2.hubspot.net/hubfs/2359995/LaunchWorks%20logo%20and%20tag_RGB.png" }, "name" : "LaunchWorks CDMO", "url" : "https://www.launchworkscdmo.com/blog/fda-registered" } ``` ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "abstract" : "LaunchWorks Manufacturing Lab is an FDA Registered, ISO 13485 certified & cGMP compliant CMO partner in genomic product commercialization in Massachusetts.", "author" : { "@type" : "Person", "name" : "LaunchWorks" }, "dateModified" : "", "datePublished" : "", "headline" : "LaunchWorks Manufacturing Lab is now FDA Registered, cGMP Compliant and ISO 13485:2016 Certified by TUV for the third time!", "image" : "https://cdn2.hubspot.net/hubfs/2359995/ErrorProofing.png", "inLanguage" : "en-us", "keywords" : "[Insider]", "mainEntityOfPage" : { "@type" : "WebPage" }, "name" : "LaunchWorks Manufacturing Lab is now FDA Registered, cGMP Compliant and ISO 13485:2016 Certified by TUV for the third time!", "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://cdn2.hubspot.net/hubfs/2359995/LaunchWorks%20logo%20and%20tag_RGB.png" }, "name" : "LaunchWorks CDMO" }, "text" : "So what’s that do for a startup biotech or new life science product launch you ask? Good question! Here is the short answer for you; Our FDA Registration will give our customers increased traceability to the FDA by registering LaunchWorks Manufacturing Lab as their manufacturing partner. cGMP Compliance provides our customers added assurance that we follow FDA cGMP Compliance for medical devices. Being ISO 13485:2016 Certified allows our customers to gain confidence that we have been audited by a third party and that we follow all the applicable regulations under the scope of our ISO certification If you would like to know more about these quality assurance claim’s please review the links in this post to the related documentation. Our QA team is available to answer questions through our “Contact Us” form as well.", "url" : "https://www.launchworkscdmo.com/blog/fda-registered", "wordCount" : "321" } ```