Leonard eisner

This article discusses the IEC 60601 Amendments Project, for Medical Electrical Safety, some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the 60601 series of standards is also discussed.

EMC Consulting Keith Armstrong graduated in 1972 from Imperial College, London, specializing in electronic design and...

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

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.

This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices.

Why are home use medical and wellness devices drawing so much attention and growing at an explosive rate?