IEC 60601 3rd Edition – The 3 Collaterals Posted by Bob Duffy on May 25, 2018 in Design, Device Tips Collateral, Design, Development, Risk Management, Software, Usability, Validation, Verification View
ISO 13485, Part 1 Posted by Bob Duffy on April 15, 2018 in Device Tips, Regulatory & Standards Compliance Establishment, Exporter, FDA, Foreign, Importer, Manufacturer, QSR, Specification View
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
