Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” 1 Earlier this month, the Food and Drug Administration’s Device ...

Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...

Globally, the medical industry is continuously growing and is highly dependent on technological advancements and essential procedures aimed at producing the best treatments. To make sure proper ...

NORCROSS, GA--(Marketwired - Sep 11, 2013) - RayBiotech, Inc. announced today that the company has been awarded ISO 13485: 2003 certification with respect to its compliance in the manufacture of in ...

The 2003 version of ISO 13485 is organized differently than the 1996 version. Much of the change is related to the prescribed process approach (as opposed to procedures or elements) and such a ...

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to ...

FREMONT, CA--(Marketwired - Dec 15, 2014) - AMAX, a leading manufacturer of High Performance Computing (HPC), dynamic Data Center/Cloud and custom Server Appliance solutions, continues to ...

ALAMEDA, Calif.--(BUSINESS WIRE)--Alveo Technologies, Inc. (Alveo), a leader in molecular sensing and diagnostics with its proprietary be.well ™ technology platform, today announced its quality ...

Asuragen, Inc., today announced that it has received ISO 13485 and 9001 certification for the quality management system for its medical devices. Asuragen undertook the more rigorous medical device ...