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Services Overview

Our unique OEM services


Turn an idea into a real medical device with the help of Lithotech’s highly experienced R&D team and fully integrated solutions. Our OEM services have been used time and time again, resulting in over 100 development projects and dozens of Nitinol-based devices already on the market. We would be happy to provide you with efficient service, rapid prototyping and unique manufacturing – as well as regulatory support. With our expertise, it doesn’t matter what size, shape or medical application you require. We are here to design, test, enhance and produce your Nitinol-based concept.

Product Design and Development Services

Shaping your needs and ideas into a conceptual design is possible with the aid of our multidisciplinary R&D team, who will provide you with a quick response for evaluating and analyzing your optimal solution. Using state-of-the-art CAD tools, well-equipped measuring and testing labs, and our in-house workshop capabilities – you will truly benefit from our rapid prototyping.

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Conceptual Design
Feasibility study
Process development
Modeling
Design
Prototyping

Product Testing Support

Benefit from our vast development experience, professional know-how and support – as we provide you all your product testing requirements.

Product-testing-support
Microbiological testing
Mechanical testing
Performance testing
Chemical analysis




Regulatory Services

Turn your ideas into real medical devices with the help of our vast experience and knowhow of medical device regulatory requirements. Our regulatory team would be happy to assist you in all regulatory aspects of your concept.

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Regulatory strategy development
Medical device standard assessment
Global regulatory compliance
Risk management
Submission support
Return products investigation

Engineering Services

Take your products from the design of a concept to the mass manufacturing of an actual device with the help of Lithotech, who will guide you every step of the way – thanks to the proven track record of our highly experienced engineering team, who has already put dozens of medical devices on the market.

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Process development
Process validation
Design transfer
Test method validation
Packagingand transportation validation
Packaging and transportation validation
Process development

Preclinical services

Lithotech has vast experience in conducting preclinical studies at various sites using different animal models, and in supporting GLP and non-GLP preclinical studies. We would be happy to assist you in preparing study documents and all necessary requirements for Helsinki committees.

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Design and execution of pre clinical studies
Development of animal study protocol and reports
Design and material optimized low volume manufacturing

Manufacturing

Lithotech is an ISO 9001 & 13485 certified facility, with over 10,000 sq. feet of controlled environment assembly floor. Our production floor facilitates over 80 manual assembly stations, with highly experienced manufacturing workers. You will benefit from large-scale production that meets your schedule.

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ISO and GMP specification
Process validation

how can we help you to launch your idea?

Contact us and start your project





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Lithotech Group

76 Yigal Alon Street, 6th floor
Tel Aviv ,6706701
Israel.

contact

E / mail@lithotech.co.il
T / +972-4-6738600
F / +972-4-6850428