Shay GinsbourgRegulatory & Testing Affairs Consultant for GINSBOURG.COM

sginsbourg@gmail.com

Summary"My approach is to focus on the business results that my clients are trying to achieve, and the business value

that they can produce by using my services, in order to pursue their business goals and objectives."

WWW.GINSBOURG.COM

Independent Software & Medical Device Professional

Formerly LoadRunner QA manager for Mercury Interactive Ltd.

Expert in verification and validation of software and medical devices.

Expert in performance and load testing of web and mobile systems.

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ExperienceRegulatory & Testing Affairs Consultant at GINSBOURG.COMJanuary 2008 - Present (6 years 8 months)

Regulatory & Testing Affairs Consultant

My appreciated customers:

* Applango * Arad Technologies * Astea Israel * BioControl Medical * Biometrix * Cognifit * DoItWise *

Earlysense * Flometrica * Given Imaging * Gixoo * Harel Insurance * Hera-Med * Hewlett-Packard * IBM

WorkLight * Idit Software Solutions * In-House * Israeli Ministry of Finance * Israeli Standards Institute *

Medimop Medical Projects * Menora Insurance * Mentors Channel * Mominis * Ness Technologies *

ORAM International * Orpak * Partner-Orange * Peer39 * Pneumedicare * RealCommerce * SafeCharge

International * Shaker * Shefa Amirim * Strauss-Water Tami4 * Tact-Matrix * TaKaDu * Tel-Aviv

University * Tescom-ONE * TesTeam QHR * Tuttnauer * Verix * Visionix * Visionsense * West *

WinBuyer * XMPie-Xerox * YCD Multimedia *

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Providing Regulatory, Medical & Performance Testing services since 2008:

* IEC 62304 Medical Device Software Life Cycle * IEEE 829 Software Test Documentation * ISO 14971

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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 *

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3 recommendations available upon request

Head of QA at Paieon Medical2007 - 2008 (1 year)

Technology:

3D Cardiac PTCA Modeling

Responsibility:

Managed a team of 5 software QA engineers.

Developed validation plans for FDA & CE product submissions

Engineered the software testing automation program

Project Operations & Software QA Manager at Cadent Ltd.2002 - 2007 (5 years)

Technology:

3D Dental Modeling & Application

Responsibility:

Recruited and managed for 5 years a team of hardware and software testing engineers verifying and

validating 3D dental imaging software and dental devices.

Managed subcontractors and delivered advanced dental devices in prompt hardware production projects.

Engineered a huge virtual catalog of dental appliances.

Significantly increased product reliability and manufacturability by utilizing internal and external resources.

3 recommendations available upon request

QA Manager of LoadRunner at Mercury Interactive1999 - 2002 (3 years)

Technology:

Software QA Tools (Industry Standards)

Responsibility:

Established and managed for 3 years a QA department constructed of 5 QA teams counting a total of 20

software testing engineers verifying and validating the company’s flagship load testing products.

1 recommendation available upon request

ISO 9000 Project Manager at Tedea-Huntleigh1992 - 1993 (1 year)

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Composed and implemented a full set of Quality System procedures in accordance with BSI regulatory

requirements.

Officer for Quality Assurance Unit at Ordnance Corps IDF1989 - 1992 (3 years)

Quality Surveillance of local industry - design and production. Performed regulatory quality audits. Defined

inspection and test procedures for mechanical weapon systems.

PublicationsHuman Erythrocyte Filterability at Low Driving PressureClinical Hemorheology and Microcirculation 2009

Authors: Shay Ginsbourg, Shay Ginsbourg, Dr. Shlomo Levin MD, Prof. Shmuel Einav, Prof. Rafi Korenstein

Abstract

In this study, the human RBC capillary flow has been modeled by passing 11 µl of RBC suspension

(Hematocrit = 6%) in phosphate buffer solution (PBS) of a viscosity of 1 and 2.6 cP (in the presence of 2%

Dextran) through 5 µm pore diameter polycarbonate Nuclepore filters. We have developed a digitally

controlled experimental system for measuring the RBC filterability at a constant driving pressure, in the range

of 10–400 Pa, producing a wall shear stress range of 1–50 Pa. The RBC filterability was evaluated by

measuring the cell suspension flow rate normalized by the PBS flow rate. The RBC filterability has been

found to be a nonlinear function of the driving pressure, having a single minimum locus at 25 Pa. Lowering

the driving pressure below 25 Pa revealed an unexpected increase of the RBC filterability.

The maximal RBC filterability (near unity) was detected at the lowest driving pressure (10 Pa) and the

corresponding estimated RBC linear velocity while traveling through the capillary pore was as high as 800

µm/s. Increasing the driving pressure above 25 Pa confirmed previous results, where RBC filterability is

monotonically and asymptotically increasing. Increasing the PBS medium viscosity from 1 to 2.26 cP

significantly attenuated the RBC filterability and led to the anomalous increase of RBC deformability at the

10 Pa pressure range. We propose that the anomalous increase in RBC deformability was caused by RBCs

undergoing spontaneous mechanical fluctuations.

Keywords

RBC deformability, low Reynolds number, spontaneous mechanical fluctuations, Dextran solution viscosity,

polycarbonate Nuclepore filters, wall shear stress

Courses

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M.Sc. Cum Laude, Bio-Medical EngineeringTel Aviv University

Coronary FlowCardiovascular blood flowPhysiology

Diploma, Software EngineeringHamaslool Ha'akademi shel Hamichlala Leminhal

UNIXNetworksProgrammingAlgorithms

ProjectsBlood flow research2000 to 2003

Members:Shay Ginsbourg, Dr. Shlomo Levin MD, Prof. Shmuel Einav, Prof. Rafi Korenstein

Human Erythrocyte Filterability at Low Driving Pressure

Shay Ginsbourg1,2, Shlomo Levin1, Shmuel Einav2* and Rafi Korenstein1

1Department of Physiology and Pharmacology and 2Department of Bioengineering

Tel-Aviv University, Tel Aviv 69978 ISRAEL

Performance and load testing1999 to Present

Members:Shay Ginsbourg, Shadi Omari, Shadi Mousa

End to end Performance & Load Testing service from early scalability measurement and performance design

review to load test planning & preparation, test cycle management, final test results reporting, and analysis.

LanguagesEnglish (Full professional proficiency)Hebrew (Native or bilingual proficiency)

Skills & ExpertiseLoadRunnerQuality SystemsQSRSoftware Quality AssuranceFDA

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510 KValidationMedical DevicesTestingMedical SoftwareDesign ControlTest ManagementISO 13485Regression TestingTest AutomationISOProcess ValidationQTPRegulatory AffairsSystem TestingQuality AssuranceISO 14971Test Planning21 CFR Part 11Test CasesComputer System ValidationUI testingInternet Website Performance and Load TestingAutomatic Software TestingRegulatory SubmissionsDocumentationSoftware DocumentationIEC 62304 Medical Device Software Life CycleQuality AuditingIEEE 829 Software Test DocumentationISO 14971 Medical Device Risk ManagementIEC 60601-1:2005 3rd EDQuality SystemQuality ManagementMedical Device ValidationPerformance TestingCE markingLoad TestingPEMSHIPAAQuality ControlTest MethodologiesSoftware QualityV&V

EducationTel Aviv UniversityM.Sc. Cum Laude, Bio-Medical Engineering, 2000 - 2003

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Hamaslool Ha'akademi shel Hamichlala LeminhalDiploma, Software Engineering, 1996 - 1997

Technion-Machon Technologi Le' IsraelM.Sc., Mechanical Engineering, 1993 - 1996

Tel Aviv UniversityB.Sc., Mechanical Engineering, 1984 - 1989

Shazar High SchoolGraduation, Math and Physics, 1980 - 1984

Honors and Awards1. Graduated M.Sc. Cum Laude, Bio-Medical Engineering, Tel Aviv University, 2003.

2. Received Graduate Student Teaching Award in 1996.

InterestsMedical Devices, Internet Technology, Software Quality, Swimming, Yoga, Soccer Goalkeeping, Container

Gardening, Vibrational Medicine, Mixed Martial Arts, Hebrew Poetry, Bible

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Shay GinsbourgRegulatory & Testing Affairs Consultant for GINSBOURG.COM

sginsbourg@gmail.com

7 people have recommended Shay

"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 you both personally and professionally."

— Shachar Arieli, was Shay's client

"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 efficient. I warmly recommend Shay as

a SW validation expert."

— Rani Shoham, was Shay's client

"Shay help us to prepare the technical file to get the CE mark for a medical device. The dossier pass the

Notify Body inspection quickly and successfully! Thanks Shay"

— Dadi Rubinstein, was Shay's client

"Shay is a very devoted manager with high sense of responsibility and excellent people management skills."

— Uri Hoffer, Engineering Manager, Cadent, worked directly with Shay at Cadent

"Shay is a detail oriented person who considers all possibilities when performing a task. His communication

skills are of the highest quality. Because Shay always keeps the big picture in mind he is always meets his

goals."

— Susan Connelly, Customer Service Director, Cadent Inc., worked with Shay at Cadent

"Shay took ownership of projects and followed the timelines to the tee. Shay was also responssible to drive

product improvement utilizing both internal and external resources. The end result was a product that

demonstrate superb reliability and serves our company to date. I could count on Shay to be a meticulous to

timelins and details. I could have counted on Shay to pick up the task when others droped the ball."

— Oshri Segal, VP Operations, Cadent Inc., managed Shay indirectly at Cadent

"Shay is a very thorough manager with high standards for QA. He built an efficient mechanism for testing

LoadRunner in a comprehensive manner. I highly recommend shay as a QA manager"

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— Yossi Oulu, VP Load Testing, R&D, Mercury, managed Shay indirectly at Mercury Interactive

Contact Shay on LinkedIn

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