Risk Analysis Back End – Production Posted by Bob Duffy on July 29, 2019 in Device Tips, Manufacturing, Regulatory & Standards Compliance ISO 14971, Patient, Production, Risk Analysis, User View
DHF, DMR, DHR Process, Part 4 Posted by Bob Duffy on March 13, 2019 in Device Tips, Manufacturing Device History Records, DHF, DHR, DMR, QSR, Quality Assurance View
Manufacturing Equipment Qualification, Part 1, Overview Posted by Bob Duffy on July 30, 2018 in Device Tips, Manufacturing Equipment, FDA, Installation Qualification, IQ, Manufacturing, QSR, Requirements 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
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
