Risk Analysis Back End – Part 1 Posted by Bob Duffy on November 8, 2019 in Device Tips, Regulatory & Standards Compliance FDA, QSR, Risk Analysis 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
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
