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
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
ISO 13485, Part 1 Posted by Bob Duffy on April 15, 2018 in Device Tips, Regulatory & Standards Compliance Establishment, Exporter, FDA, Foreign, Importer, Manufacturer, QSR, Specification View
Establishment Registration Types Posted by Bob Duffy on March 1, 2018 in Device Tips, Regulatory & Standards Compliance Establishment, Exporter, FDA, Foreign, Importer, Manufacturer, QSR, Specification View
CE Mark Part 1, Selecting A Notified Body Posted by Bob Duffy on January 15, 2018 in Device Tips, Regulatory & Standards Compliance Canada, CE Mark, EU, Notified Body, Technical File View
