Updated PFMEA to support manufacturing startup on new Medical Device Posted by Bob Duffy on April 3, 2017 in Manufacturing Projects View
Automated Equipment Risk Management and Software Validation Posted by Bob Duffy on April 3, 2017 in Manufacturing Projects View
Created protocols for and conducted IQ, OQ and PQ for Medical Device manufacturing equipment Posted by Bob Duffy on April 3, 2017 in Manufacturing Projects View
Conducted IEC62304 Software Validation and Created Software Development Technical File for IEC 60601-1 3rd Edition submission Posted by Bob Duffy on April 3, 2017 in Design Projects View
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