Ginsbourg.com

Shay Ginsbourg - Regulatory & Testing Affairs Consultant

Web Application Performance Monitoring

Website & web application performance monitoring managed service by an automatic open-source Web Performance System (WPS). Optional cloud implementation and mobile device access.

Mobile/Cloud Web Performance & Load Testing

End to end mobile, desktop, or cloud web Performance & Load Testing managed service from early scalability measurements and performance requirements review to test planning & preparation, cycle management, results reporting, bottleneck identification, and analysis. Executed with Web Performance System (WPS).

Medical Device Software Verification & Validation

End to end V&V managed service for  from early design and specification review to test design & planning, test cycle management, test team training, final test results reporting, and analysis. #VV&T

Medical Device Verification & Validation

End to end medical device V&V managed service from specification review to complete verification and validation, test cycle management, test team training, final test results reporting, and analysis. 

Medical Device Regulatory Submission

End to end medical device regulatory managed service from technical documentation to complete verification and validation, registration, and managing until approval acceptance.

Organizational Regulatory Qualification

End to end regulatory managed service from procedure composition to registration and communication with a notified body or a regulatory authority, and final audit preparation and management.

Contact me

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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