医疗器械产品开发流程

** ITL医疗器械产品开发流程为我们提供的从概念形成到售后服务和支持全部服务的总览。**

设计遵循ISO13485和FDA GMP质量管理体系,ITL医疗器械产品开发流程带您通过我们提供的所有认证服务。

从左向右阅读,我们的全面服务涵盖医疗器械设计、开发和生产的每一方面。

项目根据客户需求而有所不同,有些客户选择在整个开发过程中与我们合作,而另一些选择我们的专家参与开发过程中较小的项目。

例如,我们从一个大学建立的概念中将Endomag Sentimag乳腺癌检测系统开发成一个完全功能化的商品(阅读此处案例研究)。在另一个方面,我们帮助气体专家Bedfont Scientific,在其转化成生产前,向其提供生产工程技术和小规模预生产单元(阅读案例研究)。

ITL产品开发周期

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News
ITL invest in new inspection system to assure quality of medical device PCB’s

Kent-based design, development and manufacturing partner, ITL Group (a Gooch & Housego company), announces further investment in its in-house SMT manufacturing facility, using optical inspection and electrical testing to boost quality of medical device PCB’s.

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Resource
Product Development for Point of Care Testing Systems

Recent years have witnessed tremendous advances in Point of Care Testing (POCT), which are a result of continuous developments in biosensors, microfluidics, assay formats, lab-on-a-chip and other complementary technologies.

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Case Study
DAME

Design Transition of a Reusable Tampon Applicator from Concept to Rapid Tooling

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Case Study
LumiPod

A complete R&D project to develop a demonstrator of the technologies that will be incorporated in future Point-of-Care (POC) devices

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