See Our Experience
Software & Quality Systems regulatory crisis management and FDA negotiations including recovery from import detentions, injunctions, consent decree negotiation, requests for consultant certifications, warning letter responses, and more...
Agile medical device software processes for FDA, TIR45 consultant, Software hazards analysis, risk management, TIR32 consultant, medical device verification and validation testing, coaching & mentoring, instructor for AAMI software validation course, and more...
Medical device software standards expert, IEC 62304 and IEC 60601-1 PEMS chairman, IEC 80002-1 medical device software risk management, IEC 80001-1, safety cases, and more...
Over 20 years experience in General Quality Systems, Regulatory Submissions, Warning letter responses, consent decrees, medical device and Quality System software validation and risk assessments, and more...
Ex-FDA 510(k) reviewer, numerous successful FDA premarket submissions for a variety of medical devices, vendor audits, QSIT inspections and developing regulatory submission strategies, and more...
Assessments/ implementation of least burdensome FDA/ISO13485 compliant QMS, design controls, SDLC. IEC62304 process, software risk management, TIR 32 committee member. Drafting software submission information, and more...
IEC62304 conformance assessment, software project management, software requirement analysis, software design, software V&V, software risk analysis, risk management, FDA software submissions, and more...
Risk based code review and real-time embedded software analysis of medical device. IEC62304 software requirement, design, V&V testing processes for FDA, ISO14971 risk management, and more...
Expertise in software V&V planning and test development. IEC 62304 software life cycle conformance, assessments, audits, requirements development and IEC 14971 risk management/hazard analysis, and more...
Sr. Validation Specialist
Requirements review, creation and remediation. Test documentation, manual and automated test development, and test execution. Experience with software validation as it relates to FDA 21CFR820 and IEC62304, and more...
Test documentation and organization, manual and automated test development specializing on hardware and embedded software, and more...
T: (813) 766-0563
T: (813) 766-0563