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
IEC 60601-1 3rd Edition, Part 4 – Risk Management Posted by Bob Duffy on May 27, 2019 in Design, Device Tips Design, IEC 60601-1 3rd Edition, Risk Management View
DHF, DMR, DHR Process, Part 4 Posted by Bob Duffy on March 13, 2019 in Device Tips, Manufacturing Device History Records, DHF, DHR, DMR, QSR, Quality Assurance 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
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
