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
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 – 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
IEC 60601-1 3rd Edition, Part 1 Differences Posted by Bob Duffy on November 20, 2012 in Regulatory & Standards Compliance IEC 60601-1, IEC 60601-1 3rd Edition, Product Development Process, Product Lifecycle, Risk Management, Software, Usability View