"It's Kind of Fun to Do the Impossible"
Walt Disney
Vision
I believe that everything one dreams of is doable and possible.
If you have a dream and you need technical expertise to advance it, I have the knowledge and experience needed for turning an idea to a product.
In my office, I will help you fulfill your dream while thinking outside the box and bring your dream to a functioning prototype.
Product development will be carried out with full consideration of customer requirements and taking into account regulatory requirements, standards and future production.
Services
DESIGN
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Prototype planning and designing
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Writing characterization documents and user settings
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Writing test protocols, executing tests on the client's site.
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Writing and accompanying the patent registration process.
Technical Support
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Assimilation of new processes.
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Process Validation: IQ, OQ, PQ
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Writing and executing V&V Engineering tests
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Fixtures and Jigs designing
Regulatory Affairs
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Technical files review
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Internal Audits
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R&D teams support
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Writing procedures
Product Development - Project Steps
Product development will be carried out with the following stages:
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Kickoff meeting, in which the idea, its purpose and its advantage over competing products will be presented.
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Formulation of user requirements from the product, definition of how and purpose of use.
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Planning a number of initial concepts and presenting them.
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Patentability survey and patent registration if required.
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Selecting a leading concept and prototype production.
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Writing test protocols and prototype testing.
About
Hi, my name is Roy Zilberman, a mechanical engineer by training.
I'm Bringing many years of experience in product development and manufacturing processes.
Over the years, I have led and guided engineering and development teams in a variety of fields and in the field of medical device in particular.
As part of my duties, I have acquired extensive knowledge in the field of regulation, a field that is an integral part of the development process.
I am certified as ISO 13485 Lead Auditor by the Standards Institution of Israel.
