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A True Partner Through
The Entire Process

Medical product design, development,
production planning & more

 

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Receive your personalized Zewski Report

What Makes Us Different?

Zewski Corporation is not just another product design firm. Development of a medical device is about more than design. For a medical device to be successful, you first must understand the safety and regulatory implications that will impact your development and have the guidance to navigate that minefield. Our work since 2004 has allowed us to hone our core focus to just that, for hospitals, corporations and universities alike. From grant funding, regulatory connections and IP contributions, to design solutions and manufacturing planning throughout our process, we prepare our clients for the journey that will take them to the market safely and legally, with a risk-vs-benefits and personal approach.

We're not the only ones that can do this, but we are the only ones that do.

Let's Discuss Your Next Project

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Feasibility
What, Why, Who and How? To bring an idea to eventual production, we first define the project, timeline, costs and prove its validity through a proof-of-concept . This pre-production design process reduces financial risks by generating concepts using more fluid methods for accommodating change as the final idea is defined.
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Development
In addition to the Design for Production work during the development process, Production Tooling and Planning take place. This process provides a step needed for production efficiency, verification and validation; here the idea is formed into a living, breathing design worthy of the utmost scrutiny and refinement until mirroring initial goals and objectives. The development process represents 40% of the work to production.
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Documentation
Design Controls, including completing Verification and Validation, are about reducing risks and confirming performance on both a regulatory platform and in the clinical setting. These activities are broad and have product performance and safety at their core, spanning the mechanical lab, the bio lab and the clinical setting. The document process represents 30% of the work to production.
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Zewski Reviews

Recognition of Service Excellence

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