Medical Device IEC 60601-1 Compliance Testing Posted by Bob Duffy on October 3, 2018 in Design Projects, Projects 510(k), Compliance Testing, IEC 60601-1, Standards 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 – Alarms Posted by Bob Duffy on August 30, 2018 in Device Tips, Regulatory & Standards Compliance Alarms, IEC 60601-1 3rd Edition, Regulatory, Standards View
New Medical Device Regulatory and Standards compliance support Posted by Bob Duffy on August 1, 2018 in Regulatory & Standards Compliance Projects 510(k), 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