New Medical Device 510(k) Preparation Posted by Bob Duffy on October 17, 2018 in Projects, Regulatory & Standards Compliance Projects 510(k), FDA, Pre-Submission 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
Supported Client’s FDA Inspection And Post-Inspection Response Posted by Bob Duffy on June 5, 2017 in Regulatory & Standards Compliance Projects FDA, Inspection, QMS View
Created Technical File for CE Mark submission Posted by Bob Duffy on April 5, 2017 in Regulatory & Standards Compliance Projects View
Obtained 510(k) Market Clearance for new Medical Device Posted by Bob Duffy on April 5, 2017 in Regulatory & Standards Compliance Projects View
Developed and implemented FDA QSR/ISO 13485 compliant Quality System for startup company Posted by Bob Duffy on April 3, 2017 in Regulatory & Standards Compliance Projects Clinical, FDA, FDB Audit, ISO 13485, Medical Device License, QSR, Quality System View
