Intended Use and Indications for Use Posted by Bob Duffy on January 6, 2015 in Device Tips, Regulatory & Standards Compliance Device Tips, FDA, Indications for Use, Intended Use, Judy Martin, Warning Letters View
IEC 60601-1 3rd Edition, Part 1 Differences Posted by Bob Duffy on November 20, 2012 in Regulatory & Standards Compliance IEC 60601-1, IEC 60601-1 3rd Edition, Product Development Process, Product Lifecycle, Risk Management, Software, Usability View
Compliance Submissions Posted by Bob Duffy on March 17, 2011 in Regulatory & Standards Compliance ANSI/AAMI EC13, Compliance Submissions, FDA Guidance Documents, IEC 60601-1 View
