Software Development Management, Part 1, Overview Posted by Bob Duffy on November 22, 2013 in Design, Device Tips Medical Device Development, Software Architecture, Software Design, Software Design Transfer, Software Development, Software Development Plan, Software Development Process, Software Requirements and Specifications, Software Validation, Software Verification View
3 C’s of Specifications Posted by Bob Duffy on September 10, 2013 in Design, Device Tips Design Input, FDA, Medical Devices, QSR, Specifications 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
Risk Analysis Mid-Section, During Design and Development Posted by Bob Duffy on March 13, 2012 in Design, Device Tips Design and Development, Design Validation, Design Verification, Risk Analysis 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
Risk Analysis & Product Requirements Posted by Bob Duffy on December 14, 2010 in Design, Device Tips Design Validation, Design Verification, Product Requirements, QSR, Risk Analysis, Specifications View
