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
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
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
ISO 13485:2016 Pt 3 – Purchasing and Production Posted by Bob Duffy on June 12, 2019 in Device Tips, Regulatory & Standards Compliance EU, ISO 13485, Non-Conforming, Outsourcing, Process Validation, Purchasing, Quality Management System, Supplier View
