Frequently Asked Questions

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About Gracon Manufacturing

Yes. Gracon Manufacturing's QMS is certified by NQA to both ISO 13485:2016 and 9001:2015 standards.
As your partner, we understand the importance of creating quality products that meet all regulatory and compliance requirements. We built our Quality System with this in mind.

Visit our Quality page for more details.

Gracon Manufacturing’s facility is in Lafayette, Colorado and a 30-minute drive to Denver International Airport. 

Yes! We would love to meet in person and have you tour our facility.

Please reach out to schedule a visit.


Yes, we have certified ISO Class 7 cleanroom and neighboring white room for assembly.

Visit our Quality page for more details.

Currently, we do not have machining capabilities on site. However, we have strong a strong network of tooling partners that help us make and maintain our molds.

Quality and Risk Mitigation

We do our due diligence to establish a seamless supply chain. We work closely with our partners to pre-ordering materials, plan production, and schedule deliveries. We are transparent and proactive in making sure we can meet deadlines. The sooner we can get involved, the better equipped we can be to plan for your project.

In addition to closely monitoring our cleanrooms particulate count, we apply multiple safeguards to reduce the risk of contamination. This includes comprehensive training for all employees to understand procedures and why they are important to your product.

Our procedures cover all aspects of our operations activities. Let us know if you’d like to know more about those procedures and we’d be happy to share the details.

Raw materials storage secluded from active work areas. Restricted access to this area and a closed material handling system safeguard material from being contaminated prior to being injection molded.

We have traceability of all materials that have entered our facility and can provide upon request.

Product Development


Yes. We utilize many forms of additive manufacturing and select the method which best suits your needs.

Our local partners can provide fast turnarounds for prototypes or for additive manufactured mold inserts for short or pre-production runs.

The life of a 3D printed insert mold vary on the materials being used and tolerances required. We have run internal tests to benchmark.

Design for manufacturing refers to designing products in a way that will result in the best manufacturing outcomes. DFM helps to identify current and potential problems and fix them in the design phase, which is the least expensive time to address them. DFM can influence all types of project decisions, including but not limited to:

  • Type and form of raw material used
  • Dimensional tolerances
  • Wall thickness and draft
  • Secondary processing, such as finishing
  • Overall method of manufacturing the product


A successful design transfer requires a joint effort and both parties are responsible for its success. If you are considering a tool transfer, give us a call to see if we are a good fit and receive a copy of our Tool Transfer Checklist.

Once an order is placed, our team goes through a validation process with the goal of part conformance and quality outputs. This process is tailored to each customer’s unique needs but can include the following:

  • Design for Manufacturing (DFM) Analysis
  • Mold analysis (Moldflow and Structure)
  • Steel and plastic material confirmation
  • Mold Specification and solution reports
  • First Article Inspection and approval
  • Process Validation

When sampling, we accept the lot if zero defects are found during inspection (C=0)

For production runs, our Acceptance Quality Level (AQL) is less than or equal to 1% (AQL=0.1)

Controlling all aspects of the supply chain is essential to the cost, delivery schedule, and quality of the product. While planning a new project we all the activities that must take place to deliver a quality product at the right time. We focus on planning, forecasting, purchasing, product assembly, quality control, packaging, and delivery. This is particularly important when there are numerous vendors and suppliers necessary to supply the raw materials and equipment for your product.

We keep a close eye on market trends and raw material availability. For added peace of mind, we might suggest approving multiple sources for raw materials or purchasing material ahead of time to mitigate risk of delays.

Contact Us if you are currently experiencing supply chain issues in your current production process.

Micro molding does not have agreed upon parameters but generally refers to smaller parts with tight tolerances.  Tell us about your project and required tolerances.

If your project is not well within our capabilities, we can help you find a proven in-house that can meet your requirements and ensure your project be a success! 

Let's Work Together

We want to understand your business and needs to deliver the best solutions. Get in touch to discuss your project or reach out with questions, requests, or more information about our capabilities.


130 Miners Drive
Lafayette, CO 80026

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