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
3 C’s of Specifications Posted by Bob Duffy on September 10, 2013 in Design, Device Tips Design Input, FDA, Medical Devices, QSR, Specifications View
Risk Analysis & Product Requirements Posted by Bob Duffy on December 14, 2010 in Design, Device Tips Design Validation, Design Verification, Product Requirements, QSR, Risk Analysis, Specifications View
FREE (or Low Cost) Design Review Posted by Bob Duffy on August 9, 2010 in Design, Device Tips Design Review, Free Design Review, Low Cost Design Review, QSR, Suppliers View
Document Hierarchy Posted by Bob Duffy on April 28, 2010 in Design, Device Tips Design Controls, Design Input, Design Output, Design Review, Design Validation, Design Verification, Project Document Hierarchy, QSR, Risk Analysis View
