Establishment Registration Types Posted by Bob Duffy on March 1, 2018 in Device Tips, Regulatory & Standards Compliance Establishment, Exporter, FDA, Foreign, Importer, Manufacturer, QSR, Specification View
CE Mark Part 1, Selecting A Notified Body Posted by Bob Duffy on January 15, 2018 in Device Tips, Regulatory & Standards Compliance Canada, CE Mark, EU, Notified Body, Technical File View
DHF, DMR, DHR Process, Part 3 Posted by Bob Duffy on December 5, 2017 in Device Tips, Manufacturing Design History File, Device History Records, Device Master Record, Device Tips, DHF, DHR, DMR View
DHF, DMR, DHR Process, Part 2 – DMR->DMR Posted by Bob Duffy on October 17, 2017 in Device Tips, Manufacturing Design History File, Device History Records, Device Master Record, Device Tips, DHF, DHR, DMR View
Specified and Developed Automated Production Final Test System Posted by Bob Duffy on June 19, 2017 in Manufacturing Projects Asia, Hardware, Requirements, Specifications View