Thursday, April 22nd, 2010
Kimball Electronics Group Inc., a subsidiary of Kimball International Inc. has announced that the company's production facility near Poznan, Poland has achieved the necessary requirements for US FDA registration and ISO 13485 certification. Both the quality certification and US FDA registration help broaden the Poland facility's package of value to ...
Posted in Business News, medtechinsider | Add Comment »
Tuesday, April 20th, 2010
The US Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency website on 19 April as part of the agency's transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions and summaries of data that provide the ...
Posted in From the Wire, US Regulatory | Add Comment »
Tuesday, May 12th, 2009
US President Barack Obama wants to give US FDA the largest funding boost in its history. His budget request calls for US$2.35 billion for fiscal year 2010, compared with US$2.06 billion in the previous fiscal year, reports the Wall Street Journal. Food safety oversight is the big winner, increasing from ...
Posted in US Regulatory, medtechinsider | Add Comment »
Tuesday, January 27th, 2009
[caption id="attachment_3999" align="alignleft" width="350" caption="Taken from MIT’s computer-modeling software, this image shows the arterial drug distribution patterns for three different scenarios of drug release in a single stent. Blood flow in this 3-D simulation is from left to right. Red represents the highest concentration of drug release and blue represents ...
Posted in Combination Products | 1 Comment »
Friday, January 23rd, 2009
Scheduled for February 24–26, a course developed by Cranfield University in collaboration with TOPRA will examine how US regulatory procedures are applied to medical technologies. Offered by Cranfield University in the United Kingdom, the course is designed to enable attendees to leave with the capability to advise their organizations about ...
Posted in US Regulatory | Add Comment »
