--- title: HSE•AG is now ISO 13485 certified description: HSE•AG, a leading provider of laboratory automation, is proud to announce that it is now certified according to the ISO 13485:2016 standard (December 2017). image: https://blog.hseag.com/hubfs/Blog%20Pictures/hse-blog-zertifikat-03.jpg --- hide-section - [Blog](https://blog.hseag.com/) - [Careers](https://www.hseag.com/hombrechtikon-systems-engineering-careers/) [** ](https://www.facebook.com/HSEAGWhereScienceAndTechnologyEvolve) [** ](https://www.linkedin.com/company/17940231/) [** ](https://www.xing.com/xbp/pages/hse-ag) [EN](https://blog.hseag.com/old/hse-ag-is-now-iso-13485-certified#) [**](https://blog.hseag.com/old/hse-ag-is-now-iso-13485-certified#) ** ** [![hseag-logo-2x.png](https://blog.hseag.com/hs-fs/hubfs/HSE%20AG%20August%202017/hseag-logo-2x.png?width=272&name=hseag-logo-2x.png "hseag-logo-2x.png")](https://www.hseag.com/) ![hseag-logo-2x.png](https://blog.hseag.com/hs-fs/hubfs/Logos/hseag-logo-2x.png?width=272&name=hseag-logo-2x.png "hseag-logo-2x.png") [< Prev ](https://blog.hseag.com/old/hse-ag-agbt-orlando-fl) [HSE•AG will be at AGBT in Orlando, FL, USA from February 12–15, 2018](https://blog.hseag.com/old/hse-ag-agbt-orlando-fl) 9 February, 2018 [**](https://blog.hseag.com/) [Next > ](https://blog.hseag.com/old/agbt-2018-conference-day-1) [Day 1: First impressions of Advances in Genome Biology and Technology (AGBT) 2018](https://blog.hseag.com/old/agbt-2018-conference-day-1) 9 February, 2018 [News & Updates](https://blog.hseag.com/old/tag/news-updates) # HSE•AG is now ISO 13485 certified Feb 9, 2018 6:36:44 PM ![hse-blog-zertifikat-03](https://blog.hseag.com/hubfs/Blog%20Pictures/hse-blog-zertifikat-03.jpg) HSE•AG, a leading provider of laboratory automation, is proud to announce that it is now certified according to the ISO 13485:2016 standard (December 2017). **Why ISO 13485?** ISO 13485 is a standard that defines the requirements for the implementation and maintenance of an independently audited quality management system. It is strongly aligned with the FDA’s Quality System Regulation 21 CFR Part 820 (cGMP) and is considered to be best practice for quality management systems in the medical device industry. The ISO 13485:2016 international standard requires consistent fulfillment of customer and applicable regulatory requirements relating to the safety and performance of medical devices. By gaining this important and internationally recognized certification, we have achieved a very important milestone in the history of our young company. It provides a foundation for expanding our business activities and providing customers with high-quality services in the medical device and in vitro diagnostic markets. **About HSE•AG** [Hombrechtikon Systems Engineering AG (HSE•AG)](https://www.hseag.com/about-hombrechtikon-systems-engineering-ag/) has been at the leading edge of lab automation for 20 years. With this proven track record, we are committed to developing automated systems that enable science and technology to evolve and accelerate your next breakthrough. A prerequisite for this is application-centric development of integrated systems. HSE•AG customizes innovations to specific customer needs and provide support at the interface of systems engineering and in vitro applications. HSE•AG’s track record in applications and technologies such as next-generation sequencing, PCR, capillary electrophoresis, liquid handling, and sample preparation enables the company to successfully handle the complexities of workflow automation. Do you want to see the HSE•AG ISO 13485:2016 certificate? Download this certificate by clicking on the button below:    [![DOWNLOAD ISO CERTIFICATE](https://hubspot-no-cache-eu1-prod.s3.amazonaws.com/cta/default/3399857/8424702d-b91c-498b-83bd-84b93fbc7875.png)](https://hubspot-cta-redirect-eu1-prod.s3.amazonaws.com/cta/redirect/3399857/8424702d-b91c-498b-83bd-84b93fbc7875)    Posted by Patrick Widler ![](https://app.hubspot.com/settings/avatar/9fad713d25c9de37cd8d30744494334c) ** ### RECENT POSTS [Processes, the driving force in projects](https://blog.hseag.com/old/making-processes-the-driving-force) Jun 30, 2022 8:15:00 AM [The Engineering Key to Economic Syndromic Testing Success](https://blog.hseag.com/old/the-engineering-key-to-economic-syndromic-testing-success) Nov 24, 2021 3:07:29 PM [Meet Us at DxPx conference in Düsseldorf](https://blog.hseag.com/old/dxpx-conference-2021) Oct 29, 2021 1:55:47 PM [Video: Speed up Robotics in Conjunction with Smart AI – Enabling Improved Business Cases](https://blog.hseag.com/old/webinar-robotics-smart-ai) Jun 30, 2021 10:47:07 AM [Meet Us at FUTURE LABS LIVE 2021 and Attend Our Smart AI Webinar!](https://blog.hseag.com/old/future-labs-live-2021) Jun 1, 2021 1:59:23 PM [❄️ Season's Greetings ☃️](https://blog.hseag.com/old/seasons-greetings-2020) Dec 16, 2020 2:05:53 PM [HSE•AG closing another succesful year - Annual Report 2019](https://blog.hseag.com/old/annual-report-2019) Aug 20, 2020 10:59:38 AM [Video: Microfluidics Is Not The Challenge – Everything Around It Is!](https://blog.hseag.com/old/webinar-microfluidics-diagnostics) Aug 18, 2020 1:05:27 PM [Farewell Mirjana — Special Agent Kozulic Is Retiring](https://blog.hseag.com/old/mirjana-kozulic-retiring) Jun 25, 2020 9:31:20 AM [Meet Us at SLAS Transformed 2020 and Attend Our Microfluidics Webinar!](https://blog.hseag.com/old/slas-transformed-2020-microfluidics-webinar) Jun 9, 2020 8:51:06 AM [![](https://blog.hseag.com/hs-fs/hubfs/hseagohnesubzeile_farb-1.png?noresize&width=150&name=hseagohnesubzeile_farb-1.png)](https://www.hseag.com) Our mission is to create the tools that unravel the secrets of life – one life science & technological breakthrough at a time. By combining our engineering and application experience we create and manage complete or partial system solutions and adapt to specific customer needs to simplify their and the end users’ workflows. #### CONTACT Headquarters Garstligweg 6 CH-8634 Hombrechtikon Switzerland Phone: [+41 55 254 04 00](tel:#41552540400) Email: [info@hseag.com](mailto:info@hseag.com) North America Boston, MA USA Phone: [+1 774 433 9569](tel:+17744339569) Email: [info@hseag.com](mailto:info@hseag.com) #### NAVIGATION [Your Challenge](https://www.hseag.com/life-science-and-diagnostic-providers-challenges/) [Your Market](https://www.hseag.com/lab-equipment-markets/) [Our Solutions](https://www.hseag.com/systems-engineering-solutions/) [Our References](https://www.hseag.com/our-references/) [About Us](https://www.hseag.com/about-hombrechtikon-systems-engineering-ag/) [Blog](https://blog.hseag.com/) [Careers](https://www.hseag.com/hombrechtikon-systems-engineering-careers/) © 2018 Hombrechtikon Systems Engineering AG - All Rights Reserved [Legal](https://www.hseag.com/hombrechtikon-systems-engineering-ag-legal) | [Imprint ](https://www.hseag.com/imprint-hombrechtikon-systems-engineering-ag/) [**](https://www.facebook.com/HSEAGWhereScienceAndTechnologyEvolve) [**](https://www.linkedin.com/company/17940231/) [** ](https://www.xing.com/xbp/pages/hse-ag) ** ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Patrick Widler", "url" : "https://blog.hseag.com/old/author/patrick-widler" }, "datePublished" : "2018-02-09T17:36:44.000Z", "headline" : "HSE•AG is now ISO 13485 certified", "image" : [ "https://blog.hseag.com/hubfs/Blog%20Pictures/hse-blog-zertifikat-03.jpg" ], "mainEntityOfPage" : { "@id" : "https://blog.hseag.com/old/hse-ag-is-now-iso-13485-certified", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://blog.hseag.com/hubfs/logo-hubspot-rot.png" }, "name" : "HSE AG" } } ```