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
Supported Client’s FDA Inspection And Post-Inspection Response Posted by Bob Duffy on June 5, 2017 in Regulatory & Standards Compliance Projects FDA, Inspection, QMS View
Developed and implemented FDA QSR/ISO 13485 compliant Quality System for startup company Posted by Bob Duffy on April 3, 2017 in Regulatory & Standards Compliance Projects Clinical, FDA, FDB Audit, ISO 13485, Medical Device License, QSR, Quality System View
