Success in the medical device industry requires more than just creating a good product – you must meet regulatory standards for your device to make a difference. That’s why when designing, building, or selling medical devices, it’s important to know and understand the FDA’s classification of your...
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Update 11/19: It’s been interesting to see that since we published this piece, a sense persists that tech companies are more interested in developing wearables than consumers are in buying them. This recent article from The Economist has an interesting take, arguing that the challenge for wearables...
Read MoreFor actual Medical Device Manufacturers, the question posed in the title of this article may seem a little silly. Medical Device Manufacturers obviously know who monitors, regulates, and audits them, and who they have to answer to when something goes wrong. For the rest of us though? We are left...
Read MoreFormerly reserved for the medical, pharmaceutical, and micro-electronics industries, clean rooms have become more widespread and prevalent across the world as the tech industry has continued to boom, and regulations have constricted their grasp on more quality control departments.
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Below is a brief history of Medical Device Regulation in the United States over the past 80 or so years. Key moments have been highlighted that reflect the changing landscape in Medical Devices.
Read MoreWith the Affordable Care Act sweeping healthcare in the U.S., hospital supply chains have had the spotlight shown on them: a somewhat disregarded discipline in a hospital has now come to the forefront in cost savings.
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21CFR11 is to Food and Pharmaceutical professionals what Dr. Kelso was to Sacred Heart Hospital in the television series Scrubs. Annoying, but necessary.
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We build devices that monitor temperature, humidity, and water pressure. This much you probably know. But, we are interested any and all monitoring, sensing, and data collection, specifically to the industries that we serve. Hospitals use our temperature data loggers to keep track of vaccine...
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This article completes our series of "Warehouse Audit Survival Guides" published in Dickson Insights. If you missed our guides on the Pharmaceutical and Food industries, you can find them by clicking here and here.
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