The FDA is providing the Medical Device Innovation Consortium (MDIC) with nearly $500,000 to conduct research to better understand patient preferences, and how to integrate such preferences into the development of medical devices, the group ...
Food safety, product tracing, and product recalls are currently at the forefront of both government regulations and industry concerns around the world as the industry prepares for new regulations around certain non-food, non-healthcare ...
Tags: Packaging, Printing, Food safety
Zimmer Holdings announced Thursday that it will acquire Biomet in a $13.5 billion transaction that will provide it with a leading position in the $45 billion musculoskeletal industry. The merger between the two Warsaw, IN–based ...
Intuitive Surgical stock fell 11.5% in value on Wednesday after a disappointing quarterly earnings report and the FDA raising cancer concerns over how robotic hysterectomies are performed. The Sunnyvale, CA–based maker of da Vinci ...
Professor Ellis, who runs the Sleep Research Centre at Northumbria University, celebrated his new Professor status in the presence of world leading industry peers at an inauguration ceremony at Northumbria University on 2nd April. Jason ...
Tags: Furniture, Furnishing
In a development that sounds as if it was lifted from the storyline of a vampire melodrama, a British research consortium has announced that it is well on its way to producing human blood on a scale that makes transfusions into real people ...
From a zipper-like wound closure device that can be peeled off at home to a telemedicine robot, there are plenty of ingenious devices included as finalists in this year's Medical Design Excellence Awards. It is worth noting, however, that ...
Tags: Reshaping Medtech, Health, Medicine
Applied Silicone Corporation,a global supplier of long-term implantable silicones for the medical device and critical healthcare market, introduces medical grade silicone Adhesive Gels optimized for scar management products. Traditional ...
The common stock of healthcare and medical device giant Johnson & Johnson (JNJ) soared to recent highs following the company's announcement of first quarter results that beat analysts' estimates. The company's robust performance was ...
Tags: Health, Medicine, medical device
The FDA appears to be issuing another Class I designation involving Abbott Laboratories' voluntary recall of diabetes products. Back in January, the FDA said FreeStyle and FreeStyle Lite test strips could cause serious injury or death ...
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 ...
Tags: ISO 13485, certification
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) ...
Tags: QSR, certification
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 ...
Tags: GMP, certification
The recall process for therapeutic goods in the Australian healthcare sector is set to become streamlined with GS1 Recallnet Healthcare having gone live. Developed over four years by GS1 Australia in association with the National E-Health ...