medical devices

As part of its effort to create a more formalized system of registration requirements,...

A recent survey conducted by the Emergo Group indicates that 2017 is expected to...

The publication of new European Union (EU) regulations addressing medical devices and in vitro...

The risk management requirements of EN/IEC/ANSI/AMIEE 60601-1-2 Edition 3 (2007) and IEC 60601-1-2 Edition 4 (2014) are mostly either ignored or misunderstood by manufacturers, their EMC test labs, and medical regulatory assessors.

The U.S. Food and Drug Administration (FDA) has issued a final version of its...

ANVISA, Brazil’s medical device market regulator, has announced new clinical evaluation requirements that are...

The U.S. Food and Drug Administration (FDA) is reporting the voluntary recall of certain...

Johnson & Johnson has issued a warning to diabetes patients and their doctors that...

In an effort to make information on the use of certain higher-risk home-use medical...

The U.S. Food and Drug Administration (FDA) and medical device manufacturer St. Jude Medical...