IEC 60601 Amendments Presentation Now on MDG Premium

IEC 60601 Amendments Presentation Now on MDG Premium

Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.

Interpretation Sheet on Essential Performance & Single Fault Condition for IEC 60601-1:2005+A1:2012

Interpretation Sheet on Essential Performance & Single Fault Condition for IEC 60601-1:2005+A1:2012

Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published. The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly. In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.

FDA Announces Consensus Standards Guidances, Podcast & Webinar

FDA Announces Consensus Standards Guidances, Podcast & Webinar

On September 13, 2018 the FDA posted 2 Guidance Documents Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance Podcast on Standards & FDA’s Release

Standards & Regulatory Update – Medical Electrical Devices – Article

Standards & Regulatory Update – Medical Electrical Devices – Article

In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents.  I start up at the International level (IEC & ISO)

Free Webinar – What You Need to Know About Medical Electrical Standards Updates

Free Webinar – What You Need to Know About Medical Electrical Standards Updates

Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a webinar “What You Need to Know About Medical Electrical Equipment