Standards and Compliance

In this column, we’ll discuss the International Organization for Standardization’s recently published ISO 45001 standard, its parallels with risk communication on products and its implications for workplace safety.

The FDA has issued a Final Order that exempts certain Class II medical devices from the agency’s premarket notification (510(k)) requirements.

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.

The International Medical Device Regulators Forum has recently issued drafts of two separate guidance documents that may be of interest to medical device manufacturers.

Enter SEMI E176-1017. It places the focus not on limited types of emission from any particular equipment, but on EMI in the overall manufacturing environment and in key locations where it specifically matters.

Beginning with its initial release in 2002, the IEC 62133 family of standards has enabled international harmonization of safety testing for small-format cells and batteries. Since then, the standard has seen a major revision in 2012 and, most recently, a very significant change in 2017. This article will detail those latest changes and their impact on compliance activities.

Ethernet TCP/IP protocol is a staple in control room, network backbone and access link environments. The installation of technologies such as IP phones, wireless access points, security cameras and LED lighting has grown exponentially.

The FDA has published a guidance document intended to help manufacturers and developers of medical device applications understand and apply the agency’s new regulations regarding the acceptance of clinical data in support of requests for FDA approval.

After a somewhat mixed performance in 2017, medical device manufacturers have scaled back their expectations for anticipated growth in 2018, according to a recent survey by The Emergo Group.