4 Types of FDA Inspections and What They Mean to Medical Manufacturers

There are many different criteria which medical manufacturing companies and medical instrument companies are required to meet for FDA approval. One of these areas is the inspection of medical device manufacturers.  If you are in the medical instrumentation industry, how do you successfully and seamlessly bring compliant medical devices to market? 

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Topics: KMC Systems, Medical Product Manufacturing, medical device manufacturing, medical device design and manufacturing, medical device quality assurance

Designing Medical Devices for Use Environments in Today's Rapidly Growing POC Marketplace

With the growing demand for delivering test results as soon as possible to the patient and physician, more complex point-of-care instrumentation is hitting the marketplace at a rapid pace. Now medical device design is more complicated due to myriad considerations that must factor in to the development and design of near-patient and in-home devices

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Topics: medical device design, medical device design and manufacturing

Are you ready for manufacturing? Find out with this Manufacturing Readiness Review checklist.

How do you turn your groundbreaking idea into innovative new medical instrumentation? You may have even devoted hours developing the concept and designing a prototype, so what's next? Are you ready for manufacturing? Has your prototype gone through the proper scrutiny and testing to transition to manufacturing? How about quality control and requirements?

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Topics: medical contract manufacturers, medical device design and manufacturing

Top 5 Criteria for Choosing a Medical Contract Manufacturer

Top 5 Criteria for Choosing a Medical Contract Manufacturer

If you're a medical instrument company considering medical contract manufacturing service providers for your next project, the following criteria can set you up for a successful partnership. These top five tips will help you to create a list of challenges and concerns and conduct a comparative analysis based on the following: 

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Topics: medical device contract manufacturing, medical contract manufacturing, medical device design and manufacturing

Every Step Matters - Transitioning From Design to Manufacturing

In a relatively short span of time, medical instrumentation has run the gamut in dimension, size, scale, complexity, automation and application. Evolving from huge instruments that occupy the majority of a laboratory and require hours or days to process, to handheld point-of-care analyzers that provide instantaenous results, medical technology has made huge strides. 

If you're in the medical device business, you realize that you too must evolve to stay in step with the rapidly changing market - or get left behind. 

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Topics: medical device design and manufacturing

5 Steps for Smooth Transition to Manufacturing


In an increasingly challenging market, the process of medical device design and manufacturing can have many inherent challenges. One of the key make-or-break phases of taking a product from concept to commercialization is the degree of success in transitioning an instrument from development and design to production. Here are five tips for success.

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Topics: medical device design and manufacturing

Introducing Medical Devices to Market with the Help of Systems Engineering

Ensuring successful introduction to market is no small feat. Product development first starts with accurately documenting requirements prior to design, which secures the developed product will meet the intended use.  Read More

Topics: medical device design, medical device design and manufacturing, medical device quality assurance, Systems Engineering

Webinar: The Development, Design of Rapid Real-Time PCR Instrumention

Challenge: develop and design a new rapid, real-time PCR instrument with multiple rapid, randomly accessible thermal blocks and easy to use software that provides researchers and laboratory clinician’s flexibility in workflow with results in 20 minutes.

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Topics: medical device design, medical contract manufacturing, medical device design and manufacturing, medical device contract design, medical device development and design, real-time PCR instruments

3 Technologies Changing Medical Contract Manufacturing Supply Chain

A report1 published by the IBM Institute for Business Value declares that three emerging technologies have the power to transition the world from “a hardware-based to a software-defined global supply chain” and that these technologies will radically alter the nature of manufacturing as we know it. 

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Topics: medical device manufacturer, medical device contract manufacturer, medical device contract manufacturing, News, medical device manufacturing, medical contract manufacturing, medical device design and manufacturing, medical device development and manufacturing, medical device development, medical product outsourcing, software engineering, mechanical engineering, robotics, medical robotics, medical device supply chain management, medical devices supply chain

Take It To The Top: Team catches helicopter to 'Forbidden Mountains'

Yesterday, we received the following message from the Take It To The Top VICE Expedition team:

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Topics: KMC360, KMC Systems, Take It To The Top, medical device design and manufacturing