Content, Community & Collaboration for Medical Technology
A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).
A medical device company has to submit a product for PMA when it manufactures or makes changes and…
Added by Compliance4all on May 25, 2016 at 6:07am — No Comments
COMMUNILATOR WILL HELP TRANSFORM GLOBAL MEDICINE, DOCTORS WITHOUT BORDERS, INTERNATIONAL COMMERCE, MISSION-WORK AND WAR ZONE COMMUNICATIONS
RantNetwork’s Communilator™ is the most advanced mobile phone language translation application in the world. It is capable of recognizing and translating foreign text, including books, newspapers, and menus in 54 languages and dialects captured with the host’s mobile phone camera delivering translations in over 3,000 language pairs,…
Added by Kelly Lewis on June 18, 2012 at 4:00pm — No Comments
Many harbor the concept that the recently passed reform legislation – The Patient Access and Affordable Care Act – will mean even greater advances in medical science. This is a misconception.
The reform bill is all about access to care – getting those without insurance to get insurance either through the commercial market place or through Medicaid. This will create at least 31 million more individuals with Medicaid, will keep young adults on their parent’s insurance for a…Continue
Added by Stephen C Schimpff on March 7, 2012 at 10:30am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 13, 2008 at 6:30am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 1, 2008 at 6:00pm — No Comments