medical devices

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...

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to...

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on...