Shay Ginsbourg
Software Engineer, Volunteer, and Consultant in Tel Aviv-Yafo, Israel
Formerly QA Manager of LoadRunner at Mercury Interactive
M.Sc. cum laude in Bio-Medical Engineering
M.Sc. in Mechanical Engineering
Providing Regulatory, Medical & Performance Testing services since 2008:
* IEC 62304 Medical Device Software Life Cycle * IEEE 829 Software Test Documentation * ISO 14971 Medical Device Risk Management * FDA 21 CFR Part 11 Software Validation * CE Medical Device Directive 93/42/EEC dossier * IEC 60601-1:2005 3rd ED PEMS - Medical Electrical Equipment * End-to-end verification, validation, and testing (VV&T) * FDA and CE submissions * Open source free testing tools implementation * Functionality and regression testing * Software Performance & Load testing * Software Testing Advanced Automation * Medical Software Verification & Validation * Medical Device Verification & Validation * Medical Device Regulatory Submission * Organizational Regulatory Qualification *
Mobile: +972(0)54-6690915
Email: [email protected]
Visit my personal page on LinkedIn at: http://www.linkedin.com/in/shayginsbourg