This is What we Do Best
Designing inventive ideas into innovative products

What We Offer

We take your product from A to Z.

You can rely on us with every technical aspect of your product.

Starting from the right concept to fit the medical needs, moving to conceptual and detailed design, production and testing the prototypes for POC and V&V.

We take our customers and their products to small series production in an NPI facility, while implementing advanced production and assembly processes.

Finally, we make sure the required documentation is ready for regulatory certification and audits.

Brilliant Concepts

We combine excellent mechanical skills with vast understanding of the human body.

We solve complex problems using methodological brainstorming process with our clients while bringing our wide experience in medical devices development and processes.

Functional Prototypes

We design and build our products using CAD tools, assemble, and test them in-house.

Hands-on capabilities are essential for our work.

Our lab is well equipped with state-of-the-art tools and a variety of materials.

ISO 13485 is well-known to us, and we can work accordingly.

Production Engineering

Design for production is not a buzzword.

Our design process prioritizes production needs to minimize the gap at the NPI stage.

We plan the production process-flow, design the assembly jigs and test methods, and integrate them into a DMR.

We work closely and on-site with the leading medical device manufacturers to ensure implementation of our customer's products.

  • Conceptual Design

    Together with our clients we solve complex problems using brainstorming processes and our wide experience in medical devices development and production. 

    We deliver free-hand sketches and a requirement document.

     

  • Detailed Design & Prototyping

    We design our prototypes to simulate the functionality of the product, its planned production process and packaging limitations.

    We deliver CAD files, drawings and a physical model that can be used for proof of concept (POC).

     

  • Bench Tests and Ex-Vivo Trials

    We design and build our bench test equipment, or use organs to run the experimental trials in our lab.

    We deliver a feasibility trial protocol & report, risk analysis and an updated design.

  • Pre-Clinical Trial Preparations

    We take part at the protocol writing by defining the technical aspects of the device and its functionality. We produce the prototypes and provide a participant for the trials.

    We deliver verification protocol and report.

  • Design Transfer

    We work together with the production site to fit the design to the production's constraints and methods. We set the machines parameters, write work instructions for manufacturing, assembly and inspection according to ISO 13485 requirements.

    We deliver a production validation protocol and report required for an approved production line.

  • Technical Files

    With support of a regulatory expert, we can supply all technical documents: drawings, work instructions, V&V reports, and procedures.

    We deliver a technical file ready for ISO 13485 application.

Let's talk
About our next project
+972-4-991-9800
3 Horesh HaAlonim St., Ramat Yishay, 3009500
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