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
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
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
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
Risk Analysis Mid-Section, During Design and Development Posted by Bob Duffy on March 13, 2012 in Design, Device Tips Design and Development, Design Validation, Design Verification, Risk Analysis View
