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A unique single source solution to your product development needs: Product design, hardware & software engineering, project management,regulation compliance, sourcing and prototyping.
To ensure your project is brought ON TIME, within its PLANNED BUDGET, and that it is concluded by the DELIVERY of a smart, reliable medical device – a professional project manager will lead your project from start to finish in strict accordance to PMI principles.
With hundreds of blocks already designed and proved, it is easy to build fast prototypes, custome industrial design and application creates unique product with solid working technology.
Most projects start from the end to the start, medical device starts with the regulatory to pass that effects it’s building blocks. Fast projects starts with low risk building blocks, High performance projects starts with market technological research. After hundreds of projects we now understand that PRODUCT ARCHITECTURE is the most important stage in the project.
At Tonson-Labs we start with system architecture as one of the initial stages and it’s products escort the whole process of development.
Over 200 years of hardware design sits at our facility, after hundreds of projects we have designed analog boards, digital boards, communication boards, high speed boards, miked signal boards, almost anything you can imagine. This is just the tip of the iceberg as all designs work fist-time and pass regulatory after few weeks. now we start talking !
Our software engineers come from computer science background and are leaded by a software manager who is familiar with multi-platforms such as ARM, X86, Linux, Windows, multi-core, embedded, and RTL design. Any software starts with architecture design that stands to the test with the team and the client, if passes – it is broken to pieces and divided to the engineers.
We understand and support our clients needs, we understand that part of the medical device design process is to take the device to clinical trials. In order to support our clients we suggest a unique platform that enables the client to have a “hands on” development team to support any need, or request during the trials. This enables the client to tweak algorithms and design flaws from the field at a very fast development time.
Regulation / Standard Compliance
Most of our products (excluding prototypes) pass regulatory. This regulatory controls the development process as well as the documentation and the actual product quality. At Tonson-Labs we support full DHF and DMR files. Which means that the whole development process is recorded into the documentation this enables us to pass 60601, CE, FDA in a very fast time. Tonson-Labs comply with ISO13485 and ISO9000
Implementation: customization and localization
As every product that arrives to the market Tonson-Labs supports special customization process for each clients, this leads to several releases to support each clients needs. The process can include changes in product look and feel, documentation, guide instructions and support.