Intended Use and Indications for Use Posted by Bob Duffy on January 6, 2015 in Device Tips, Regulatory & Standards Compliance Device Tips, FDA, Indications for Use, Intended Use, Judy Martin, Warning Letters View
Quality Systems, Part 1 Posted by Bob Duffy on January 21, 2014 in Device Tips FDA, Happy Customers, Medical Devices, QMS, QS, 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
Product Requirements Posted by Bob Duffy on December 2, 2009 in Design, Device Tips Design Validation, FDA, Product Requirements and Specifications, QSR View
Project Planning Posted by Bob Duffy on September 30, 2009 in Design, Device Tips Design and Development Project Planning, Design Changes, Design Controls, Design History File, Design Input, Design Output, Design Review, Design Transfer, Design Validation, Design Verification, FDA, Medical Devices, QSR View