Prototyping

Prototyping is a crucial step in the process, especially for medical devices and biotechnology products. From functionality and usability to robustness and performance, prototyping validates how your product behaves in real‑world conditions—long before committing to mass production. At Plas-Tech Engineering, we also offer prototype tooling services that can help you achieve your product development goals and meet ISO 13485 requirements.

prototyping at plastech

At Plas-Tech Engineering, we have over 30 years of experience in prototyping for different medical devices and biotechnology products, and we have worked with customers across various related industries and markets. We use state-of-the-art equipment and technology (including CNC machining, 3D printing, injection molding, and hand assembly) to create prototypes that match your specifications and expectations.

Plas-Tech Engineering does not use aluminum for our prototype tools, as it is not suitable for medical applications. Instead, we use tool steels, which are durable, corrosion-resistant, and biocompatible. Our prototypes are built robust enough to where they can be validated via ISO 13485-2016 requirements.

In addition, our teams support with the documentation, testing, and certification processes required for regulatory approval and market launch.

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We'd love to hear about your project.

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Plas-Tech facilities are FDA registered and ISO 13485 certified

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Shipping Address:
875 Geneva Parkway N.
Lake Geneva, WI 53147

Billing Address:
P.O. Box 777
Lake Geneva, WI 53147

T:262-248-2379

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