Eisner Safety Consultants

ESC Newsletter #1 – Just Released
This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ‘09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment 2007/47/EC, our Standards & Regulations Update Service, announcement of the Medical Device Track at the Oct [...]

Regulatory Strategies for the Third Edition of IEC 60601-1 — Published September 2009 in MD&DI

The article discusses when IEC 60601-1:2005 will be mandatory, including the US, EU, & Canadian National versions.  There is a look at the development of the standard and why implementation has taken so long.  As there can be conflicting requirements [...]

Reducing Risk without Wasting Resources: Doing Risk Management Right

MD&DI May ‘09 article on Risk Management by Mike Schmidt