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OEMs: Do You Trust Your Medical Device Supplier’s Quality?
As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. That is no easy task. Ideally, your supplier’s quality systems are strong enough to...
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Are You Gambling With Medical Device Compliance?
OEMs can ease their burden of ensuring CMO regulatory compliance by selecting a CMO with a fully integrated system for DHR creation. Not only can such a system eliminate the inaccuracies of paper...
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CAPA Should Not Be Cruel And Punitive Action
In a recent guest column on Med Device Online, FDA inspectional observations were summarized for the most recent fiscal year indicating 400 of the 1,030 inspectional observations written by CDRH...
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Apple Wants a Bigger Bite of the Healthcare Fruit
The tech titan is expanding its presence in the healthcare market by putting medical records on iPhones and plans to seek FDA approval for an iWatch-connected heart app. [Read Full Article] Source:...
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This Robotic Exoskeleton Is Making the Impossible Possible
After suffering a spinal cord injury eight years ago, doctors told Paul Campbell there was only a 3% chance he would ever walk again, Campbell said after walking across a room at SXSW with the...
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Evolving To Meet The Medical Device Outsourcing Boom
A 2017 report by Grand View Research, Inc. projects the global medical device outsourcing market is expected to reach USD $88.2 billion by 2025. The market was valued at USD $33.2 billion in 2016 and...
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How to Keep Up with FDA’s Expanding UDI Requirements
September 2018 brings a new deadline. Here’s what medical device manufacturers need to do. Certain Class II Medical Devices, such as surgical scissors, scalpels, and vascular clamps, are intended to...
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I’m an Engineer, But I Can’t Fix Stupid
“You can’t fix stupid,” a phrase I’ve heard engineers use about consumers, can and should be applied to medical device companies that refuse to adapt to customer needs. Consumers lead enterprise, and...
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The Medical Device Behind the Discovery of a New Human Structure
You may have heard about the researchers who recently identified what may or may not be considered a new human organ. Now learn about the advanced imaging technology that enabled this discovery. [Read...
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Fitbit Dives Deeper in Healthcare Through Google Partnership
Fitbit has chosen Google Cloud to help with an interoperability solution that enables users to collaborate on care with healthcare providers. [Read Full Article] Source: Mddionline.com The...
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