CFR

Product liability litigation and product safety regulatory compliance are sometimes intertwined, and this can make a bad situation worse.

This article defines ionization qualification and periodic verification test procedures for ionizers which are not addressed in STM3.1 or SP3.3, including air-assist bar ionizers, soft x-ray ionizers, an alternative method of room ionization, and non-airflow alpha ionizers.

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP).

This is the first of a series of articles devoted to the design, test, and EMC emissions evaluation of 1- and 2-layer PCBs that contain AC/DC and/or DC/DC converters and employ different ground techniques.