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
IEC 60601 3rd Edition – Alarms Posted by Bob Duffy on August 30, 2018 in Device Tips, Regulatory & Standards Compliance Alarms, IEC 60601-1 3rd Edition, Regulatory, Standards View
Manufacturing Equipment Qualification, Part 1, Overview Posted by Bob Duffy on July 30, 2018 in Device Tips, Manufacturing Equipment, FDA, Installation Qualification, IQ, Manufacturing, QSR, Requirements View
CE Mark, Part 2, Conformity Assessment Pathways Posted by Bob Duffy on July 1, 2018 in Device Tips, Regulatory & Standards Compliance CE Mark, Classification, EU, Medical Device Directive, Quality Management System View
