4 Things You Need to Know About FDA Registered Manufacturers

Posted by Kevin Allison on May 23, 2018

Medical device manufacturing is a highly regulated industry. Those regulations cover the requirements for manufacturers, including contract manufacturers (CMs), to register their facilities with the FDA if they produce or work on medical devices or a device’s components. Let’s clarify what exactly FDA registration means for OEMs looking to outsource the production for their next medical device design.

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Topics: contract manufacturing

Top 4 Reasons to Manufacture Your Medical Product in a Cleanroom

Posted by Kevin Allison on Apr 26, 2018

Cleanroom manufacturing is an increasingly common part of the production of medical products. From the injection molding of components, to assembly and packaging, Class 10K and 100K cleanrooms are becoming a standard part of medical manufacturing operations.

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Topics: contract manufacturing, cleanroom, medical manufacturing

4 Current Trends for Full-Service Medical Contract Manufacturers

Posted by Kevin Allison on Apr 16, 2018

An ongoing trend in the world of contract manufacturing is the rise of the “full-service” contract manufacturer (CM): a CM that vertically integrates what used to be several activities spread along a typical supply chain. By turning to full-service medical contract manufacturers,

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Topics: contract manufacturing

What Exactly Does a Medical Contract Manufacturer Do?

Posted by Kevin Allison on Mar 22, 2018

Medical contract manufacturers fill an important niche in the medical device industry and in the general healthcare ecosystem. By outsourcing the production of medical components and even completely assembled devices, OEMs can meet delivery deadlines, reduce costs associated with production overhead, and stay lean and focused on core, value-adding activities like innovation, marketing, and strategy.  Medical contract manufacturers make components for, and even complete assemblies of products for Class I, II, & III medical devices and components.

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Topics: contract manufacturing