Software Development Management, Part 2, Software Requirements Posted by Bob Duffy on March 18, 2014 in Design, Device Tips Compound Software Requirements, Software Requirements, Software Requirements and Specifications View
Quality Systems, Part 1 Posted by Bob Duffy on January 21, 2014 in Device Tips FDA, Happy Customers, Medical Devices, QMS, QS, Quality System View
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