A study of 25 high-risk medical devices approved for use on children showed that 84 percent of those devices approved by FDA since 2008 had not been tested on any child under 18 years of age before the approval was granted. Eleven had not ...
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.[1] This ...
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Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) ...
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KNF Neuberger Inc. KNF micro air/gas diaphragm pumps are small and quiet, yet powerful and dependable. KNF micro air/gas diaphragm pumps are small and quiet, yet powerful and dependable. Providing design engineers installation flexibility ...
Tags: Industrial Equipment, Components
Valtronic Technologies (USA) Inc. Valtronic announces the acquisition of the latest leading edge surface mount assembly equipment for improved flexibility and production quality for their U.S. facility. Solon, Ohio - March 27, 2014 ...
Tags: Electrical, Electronics, Industrial Equipment, Components
ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards ...
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The United States Food and Drug Administration (FDA) Introduction FDA (FDA) under the United States Department of Health Education and Welfare, is responsible for the drugs, food, biological products, cosmetics, veterinary drugs, ...
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Good manufacturing practices (GMP) are the practices required in order to conform to guidelines laid down by agencies which control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical ...
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A spinal stimulator from Medtronic designed for chronic pain management helped four patients with paralyzed lower limbs to regain some control over their legs. In four men who had been paralyzed from the waist down, the RestoreAdvanced ...
Global Vision has selected Crest Solutions as a new reseller in Ireland and the United Kingdom (UK). Crest will resell the complete product line of Global Vision, while providing support for its customer base, under the terms of the ...
Medical device contract manufacturer Norman Noble, Inc. today announced Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-Free), an exclusive, athermal laser machining process that represents an advancement of several ...
While many media outlets are headlining the top-line numbers in today's FDA report that show that the number of medical device recalls have nearly doubled in the last 10 years, a look underneath the surface reveals that the rate of recalls ...
The conflict mineral issue is providing a perfect storm for social change. It’s also leading electronics company CEOs to understand with great discomfort just how little they truly know about their supply chains. It’s a ...
Royal DSM, the global Life Sciences and Materials Sciences company, has repurchased 254,756 of its own shares in the period from 7 March 2014 up to and including 13 March 2014 at an average price of €47.40. This is in accordance with ...
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FMI Inc. Chicago-based medical silicone component manufacturer FMI today announced a new program aimed at helping medical device companies get new projects to market faster. Chicago-based medical silicone component manufacturer FMI today ...
Tags: silicone component, medical device, Health