Standards and Compliance

The Commission of the European Union (EU) has updated the list of standards that...

The U.S. Food and Drug Administration (FDA) has released a discussion paper on the...

The safety hierarchy is a flexible concept that can be helpful in deciding on a final product design. But it can also be a trap for the unwary design engineer. This article will discuss the safety hierarchy concept, how do you comply with its requirements, and what are the problems associated with it?

The Commission of the European Union (EU) has also published requirements for providing medical...

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

The Commission of the European Union (EU) has issued its requirements for the medical...

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...

A European Union (EU) task force has issued a document intended to clarify the...

The definition of “expected service life” included in IEC 60601-1 standard potentially generates confusion and misinterpretation. This article provides an analysis of the “real-life” implications of this definition and proposes some clarifications.

This article will discuss the law of misuse and some ways in which manufacturers can practically perform a risk assessment, including an analysis of product misuse.