Prototyping

Why Prototyping Matters

• Is a crucial step in the product development process, especially for medical devices and biotechnology products.
• Allows you to test the design, functionality, usability, and performance of your product before investing in mass production.
• Can help you identify and resolve any issues or challenges that may arise during the development process, such as technical feasibility, manufacturability, quality, safety, and compliance.
• It can also help communicate your product vision to your stakeholders, customers, and regulators, as well as obtain valuable feedback and validation.

How Plas-Tech Engineering Can Help You:

• At Plas-Tech Engineering, we offer prototyping services that can help you achieve your product development goals and meet ISO 13485 and FDA standards of quality and reliability.
• 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 prototypes, 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 and FDA standards (which are the most stringent and widely recognized standards for medical devices and biotechnology products.
• In addition, we can assist you with the documentation, testing, and certification processes required for regulatory approval and market launch.