--- title: ISO 13485 Medical Manufacturing | IMA Technik description: IMA Technik starts ISO 13485 medical manufacturing implementation. Precision electromechanical assembly and HMLV solutions for MedTech leaders. image: https://imatechnik.com/hubfs/Imported_Blog_Media/MG_5126-scaled-1.jpg --- [Skip to content](https://imatechnik.com/news/iso-13485-medical-manufacturing-implementation#main) [![IMA Technik](https://imatechnik.com/hs-fs/hubfs/ima/IMA_Technik-e1718014505616.png?width=255&height=69&name=IMA_Technik-e1718014505616.png)](https://imatechnik.com/?hsLang=en) - [About us](https://imatechnik.com/about-us?hsLang=en) - [Offer](https://imatechnik.com/services?hsLang=en) - [Quality](https://imatechnik.com/quality?hsLang=en) - [References](https://imatechnik.com/references?hsLang=en) - [News](https://imatechnik.com/news?hsLang=en) [CONTACT USCONTACT](https://imatechnik.com/location?hsLang=en) - [![English](https://imatechnik.com/hubfs/raw_assets/public/ima-technik/images/flags/en.svg)](https://imatechnik.com/news/iso-13485-medical-manufacturing-implementation) - [![Deutsch](https://imatechnik.com/hubfs/raw_assets/public/ima-technik/images/flags/de.svg)](https://imatechnik.com/de/nachrichten/iso-13485-medizinische-fertigung-implementierung) - [About us](https://imatechnik.com/about-us?hsLang=en) - [Offer](https://imatechnik.com/services?hsLang=en) - [Quality](https://imatechnik.com/quality?hsLang=en) - [References](https://imatechnik.com/references?hsLang=en) - [News](https://imatechnik.com/news?hsLang=en) - [Contact](https://imatechnik.com/location?hsLang=en) ![](https://imatechnik.com/hs-fs/hubfs/raw_assets/public/ima-technik/images/photos/page-news.jpg?width=1600) 1. [Home](https://imatechnik.com/?hsLang=en) 2. [News](https://imatechnik.com/news/all) 3. IMA Technik begins preparations for ISO 13485 certification IMA TECHNIK News News # IMA Technik begins preparations for ISO 13485 certification Published: 2025-09-09 · Updated: 2026-11-12 · 2 min read On this page ![](https://imatechnik.com/hs-fs/hubfs/Imported_Blog_Media/MG_5126-scaled-1.jpg?width=1200) ![](https://imatechnik.com/hs-fs/hubfs/Imported_Blog_Media/MG_5426-1-683x1024-1.webp?width=683&height=1024&name=MG_5426-1-683x1024-1.webp) # ISO 13485 Medical Manufacturing Implementation at IMA Technik IMA Technik has officially started preparations for **I[SO 13485](https://www.iso.org/standard/59752.html) medical manufacturing** implementation to support the growing needs of the healthcare sector. Achieving this certification is a milestone that strengthens our position as a reliable partner in the global medical technology industry. It allows us to offer even more specialized **contract manufacturing** services for the most demanding MedTech projects. ## Precision Electromechanical Assembly for MedTech Leaders Expanding our presence in the medical sector is a key strategic goal, where we already collaborate with leaders such as Hamilton Medical, Tecan, and Medin. Our transition to **ISO 13485 medical manufacturing** standards ensures that our **electromechanical assembly** processes meet the highest regulatory compliance levels. We focus on delivering product quality that addresses the requirements of both current and potential international clients. ### Expertise in High-Mix, Low-Volume (HMLV) Production Our company combines years of experience in **high-mix, low-volume (HMLV) production** with a focus on innovation and safety. By integrating **mechanical assembly** with new quality protocols, we enhance our **ISO 13485 medical manufacturing** capabilities. This step ensures sustainability and efficiency in bringing safe medical devices to the market. ## Unlock Your Competitive Edge with an Expert Partner As a trusted provider of production solutions in Central Europe, IMA Technik acts as an extension of your technical team. We are ready to turn quality standards into your strategic advantage. Ready to optimize your production with a partner focused on regulatory excellence? We invite you to an [expert consultation](https://imatechnik.com/location/?hsLang=en) regarding your business development. Let’s analyze your manufacturing challenges and explore how our ISO 13485 medical manufacturing expertise can accelerate your time-to-market. ## Tags - [Assembly outsourcing](https://imatechnik.com/news/tag/assembly-outsourcing) - [Electromechanical Assembly](https://imatechnik.com/news/tag/electromechanical-assembly) - [Flexible assembly](https://imatechnik.com/news/tag/flexible-assembly) - [High-mix low-volume production](https://imatechnik.com/news/tag/high-mix-low-volume-production) - [Component assembly](https://imatechnik.com/news/tag/component-assembly) - [Contract Manufacturing](https://imatechnik.com/news/tag/contract-manufacturing) - [Contract assembly](https://imatechnik.com/news/tag/contract-assembly) - [Assembly lines](https://imatechnik.com/news/tag/assembly-lines) - [Blog](https://imatechnik.com/news/tag/blog) [← Back to all news](https://imatechnik.com/news/all) IMA TECHNIK ## Additional news articles [![](https://imatechnik.com/hs-fs/hubfs/Imported_Blog_Media/erp-1.png?width=800)](https://imatechnik.com/news/ima-technik-goes-live-with-streamsoft-prestiz-erp-to-drive-digitalization-and-process-optimization?hsLang=en) ### [IMA Technik Implements Streamsoft Prestiż ERP for Process Optimization](https://imatechnik.com/news/ima-technik-goes-live-with-streamsoft-prestiz-erp-to-drive-digitalization-and-process-optimization?hsLang=en) 2026-08-13 At IMA Technik, we are constantly striving to improve our production and operational processes. We are pleased to announce the successful implementation of the … [Read More »](https://imatechnik.com/news/ima-technik-goes-live-with-streamsoft-prestiz-erp-to-drive-digitalization-and-process-optimization?hsLang=en) [![](https://imatechnik.com/hs-fs/hubfs/Imported_Blog_Media/IMG_6674-1.jpg?width=800)](https://imatechnik.com/news/ima-technik-at-industrial-spring-2026-in-kielce?hsLang=en) ### [IMA Technik at Industrial Spring 2026 in Kielce](https://imatechnik.com/news/ima-technik-at-industrial-spring-2026-in-kielce?hsLang=en) 2026-04-08 As a company based in Kielce, IMA Technik could not miss Industrial Spring 2026 at Targi Kielce – one of the most important industrial trade fair events in … [Read More »](https://imatechnik.com/news/ima-technik-at-industrial-spring-2026-in-kielce?hsLang=en) [![](https://imatechnik.com/hs-fs/hubfs/Imported_Blog_Media/IMG_6634-1.jpg?width=800)](https://imatechnik.com/news/ima-technik-receives-gazele-biznesu-2025-award?hsLang=en) ### [IMA Technik Receives Gazele Biznesu 2025 Award](https://imatechnik.com/news/ima-technik-receives-gazele-biznesu-2025-award?hsLang=en) 2026-03-25 IMA Technik is proud to announce that we have received the Gazele Biznesu 2025 award, one of the most recognized distinctions for small and medium-sized … [Read More »](https://imatechnik.com/news/ima-technik-receives-gazele-biznesu-2025-award?hsLang=en) [![](https://imatechnik.com/hs-fs/hubfs/Imported_Blog_Media/engineer-4941347_1280-1.jpg?width=800)](https://imatechnik.com/news/contract-assembly-manufacturing?hsLang=en) ### [The All or Nothing Relocation Fallacy. 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Is Your Long Tail of Custom Orders Destroying Factory Efficiency?](https://imatechnik.com/news/expert-electromechanical-assembly-hmlv-production-guide?hsLang=en) 2026-01-26 Electromechanical assembly is the silent engine that powers modern industrial innovation—but if managed incorrectly, it becomes the silent killer of … [Read More »](https://imatechnik.com/news/expert-electromechanical-assembly-hmlv-production-guide?hsLang=en) [![IMA Technik](https://imatechnik.com/hs-fs/hubfs/raw_assets/public/ima-technik/images/logo-ima-technik.png?width=255&height=58&name=logo-ima-technik.png)](https://imatechnik.com/?hsLang=en) ## Menu - [About us](https://imatechnik.com/about-us?hsLang=en) - [Offer](https://imatechnik.com/services?hsLang=en) - [Quality](https://imatechnik.com/quality?hsLang=en) - [References](https://imatechnik.com/references?hsLang=en) - [News](https://imatechnik.com/news?hsLang=en) ## Offer - [Mechanical assembly](https://imatechnik.com/services#mechanical-assembly) - [Electrical assembly](https://imatechnik.com/services#electrical-assembly) - [Value added](https://imatechnik.com/services#value-added) - [For machine builders](https://imatechnik.com/contract-manufacturing-machine-building?hsLang=en) - [For medical technology](https://imatechnik.com/medtech?hsLang=en) - [Battery packs](https://imatechnik.com/services#battery-packs) ## Knowledge - [FAQ](https://imatechnik.com/faq?hsLang=en) ## Contact - [+48 41 331 15 02](tel:+48413311502) - [info@ima-technik.com](mailto:info@ima-technik.com) - ul. 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