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Leonard eisner

The IEC 60601 Amendment Updates Have Published: Changes and Impacts

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.

Faces In Compliance 2020

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

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?

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.

How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World

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.

Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents

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.
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