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
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
ISO 13485, Part 2 Posted by Bob Duffy on January 26, 2019 in Device Tips, Regulatory & Standards Compliance Design, EU, ISO 13485, Medical Device File, Quality Management System, Risk Management View
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
