Criterion Tool Completes FDA Registration Renewal for 2025

We are proud to announce that our FDA registration renewal has been successfully completed, reaffirming our commitment to excellence in medical device manufacturing. This renewal underscores our dedication to producing high-precision components that meet the rigorous standards of the healthcare industry.

What FDA Registration Means

The Food and Drug Administration (FDA) plays a critical role in ensuring that medical devices are safe, effective, and reliable. FDA registration demonstrates that a manufacturer’s processes, materials, and products meet stringent regulatory requirements. For a precision machining shop like Criterion Tool, this registration is essential for serving the highly regulated medical device industry.

By renewing our FDA registration, we reaffirm our ability to deliver biocompatible materials, precise manufacturing, and regulatory compliance. Ensuring every step of our process aligns with FDA guidelines.

Why This Matters for Our Customers

For medical device manufacturers, working with an FDA-registered partner provides peace of mind. It ensures that the components they rely on are produced under the highest standards of quality and safety. With our renewed registration, customers can trust Criterion Tool to deliver precision-machined components for cutting-edge medical technologies, provide full traceability and documentation to simplify regulatory submissions, and produce reliable components that perform flawlessly in critical applications.

Our Commitment to Excellence

Achieving FDA registration is no small feat, and maintaining it requires ongoing effort and dedication. At Criterion Tool, we continuously invest in:

Advanced Technology: Utilizing state-of-the-art CNC machining and inspection equipment to ensure precision.

Employee Training: Keeping our team informed about the latest industry standards and best practices.

Process Optimization: Regularly reviewing and improving our workflows to meet and exceed regulatory requirements.

This proactive approach is part of our philosophy of continuous improvement, ensuring we remain a trusted partner in medical manufacturing.