Specified and Developed Automated Production Final Test System Posted by Bob Duffy on June 19, 2017 in Manufacturing Projects Asia, Hardware, Requirements, Specifications View
Evaluated Design Changes for Adequacy of Design Verification Posted by Bob Duffy on June 12, 2017 in Design Projects Design Changes, Design Verification, Requirements, Risk Analysis, Specifications 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
Created Technical File for CE Mark submission Posted by Bob Duffy on April 5, 2017 in Regulatory & Standards Compliance Projects View
Obtained 510(k) Market Clearance for new Medical Device Posted by Bob Duffy on April 5, 2017 in Regulatory & Standards Compliance Projects 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
