Ginsbourg.com

Shay Ginsbourg - Regulatory & Testing Affairs Consultant

Experience

Regulatory & Testing Affairs Consultant
GINSBOURG.COM
Medical Device and Software Validation
2008 – Present


Head of QA
Paieon Medical Ltd.

Technology: Medical Software Device - 3D Cardiac PTCA Modeling
2007 - 2008


Project Operations & Software QA Manager
Cadent Ltd.
Technology: Medical Software & Hardware - 3D Dental Modeling & Application
2002 - 2007


QA Manager of LoadRunner & Astra LoadTest
Mercury Interactive Ltd.
Technology: Industry Standard Software QA Tools
1999 - 2002


ISO 9000 Project Manager
Tedea Huntleigh Ltd.
Technology: Electrical/Electronic Manufacturing Industry
1992 – 1993


Officer for Quality Assurance Unit
Ordnance Corps IDF

Military Industry
1989 – 1992

Education

Tel Aviv University
M.Sc. Cum Laude Bio-Medical Engineering
2000 – 2003

Graduated with Honors. Thesis title:
“Human Erythrocyte Filterability At Low Pressure Range”, 2003. 

Paper published: 
Shay Ginsbourg, Shlomo Levin, Shmuel Einav, Rafi Korenstein.
"Human Erythrocyte Filterability At Low Driving Pressure ".
Clinical Hemorheology and Microcirculation.
Vol 43' No 4, pages 309-319, 2009

Paper link:
http://iospress.metapress.com/content/6p75364734757783/?p=1f67a30a5f6a435caf2a52e5420daa81&pi=3


Technion-Machon Technologi Le' Israel
M.Sc. Mechanical Engineering
1993 – 1996


Thesis title: “Liquid Mist Surface Cooling”, 1996.
 

Tel Aviv University
B.Sc. Mechanical Engineering
1984 – 1989

Contact me

Email: Email me

Tel.: Call me

Skype: Skype me


Testimonials

  • ""Shay helped us with the preparation of all the SW related regulatory documents for the CE and FDA submission of our medical device. It was a pleasure working with him both pers..."
    Shachar Arieli
    Software & algorithms team manager at Visionsense Ltd.
  • "I hired Shay for a software validation project. He proved himself as an expert, knowing what should be done and how, and provided value by keeping the project small, simple and ..."
    Rani Shoham
    COO at BioControl Medical