Standards by Topic

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.

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.

This article will look at what causes harmful interference and how EMC regulations address them. It will examine three typical and largely encompassing cases that can be extrapolated to many other applications.

The automotive industry and individual automobile manufacturers must meet a variety of EMC requirements.

Meridian Medical Technologies, the manufacturer of Mylan’s EpiPen-brand of epinephrine auto-injectors, has announced a...

Transported lithium-based batteries are divided into two types: lithium-ion found in mobile phones and laptops, and non-rechargeable lithium-metal used in medical devices and a number of consumer grade AA, AAA and 9V batteries.

Mexico has published a new standard establishing updated energy efficiency requirements for certain lighting...

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