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
Manufacturing Equipment IQ, OQ and PQ Qualification Posted by Bob Duffy on July 1, 2018 in Manufacturing Projects Automated Equipment, IQ, OQ, PQ, Process, Test Procedures View
New Medical Device Feasibility Assessment Posted by Bob Duffy on June 14, 2018 in Design Projects Cost, Design Changes, Development, Feasibility View
IEC 60601 3rd Edition – The 3 Collaterals Posted by Bob Duffy on May 25, 2018 in Design, Device Tips Collateral, Design, Development, Risk Management, Software, Usability, Validation, Verification 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
