Quality Systems Part 2, QS Strategy Posted by Bob Duffy on December 3, 2019 in Device Tips, Regulatory & Standards Compliance FDA, ISO 13485, Quality System, Strategy View
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
Promotion and Advertising Part 2 – Agency Roles Posted by Bob Duffy on September 10, 2019 in Device Tips, Regulatory & Standards Compliance Advertising, FDA, FTC, Intended Use View
Promotion and Advertising Part 1 – Truth in Advertising Posted by Bob Duffy on July 18, 2019 in Device Tips, Regulatory & Standards Compliance Accurate, Advertising, FDA, FTC, Regulatory View
New Medical Device 510(k) Preparation Posted by Bob Duffy on October 17, 2018 in Projects, Regulatory & Standards Compliance Projects 510(k), FDA, Pre-Submission View
