Created Usability File, Risk Management File and Software Development Technical File for IEC 60601-1 3rd Edition submission Posted by Bob Duffy on April 3, 2017 in Design Projects View
Risk Analysis Mid-Section, Part 2, Process Mitigations Posted by Bob Duffy on May 19, 2016 in Device Tips, Manufacturing Design Transfer, Process Validation, Process Verification, Risk Analysis, Risk Analysis V&V View
DHF, DMR, DHR Part 1, Overview Posted by Bob Duffy on April 11, 2016 in Device Tips, Manufacturing Design History File, Device History Records, Device Master Record, Device Tips, DHF, DHR, DMR View
Complete Electronic Hardware Design Package Posted by Bob Duffy on May 19, 2015 in Design, Device Tips Electronic Hardware, Electronic Hardware Design Package, Hardware Design View
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
