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
New Medical Device Design Verification and Validation Posted by Bob Duffy on September 19, 2018 in Design Projects 510(k), Bench Testing, Design 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