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
MD&DI Sept ’09 Article on IEC 60601-1, 3rd edition
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
Reducing Risk without Wasting…
Reducing Risk without Wasting Resources: Doing Risk Management Right MD&DI May ’09 article on Risk Management by Mike Schmidt