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tom peterson

ASH now offers a Supermold ISO 13485 Validation Package

If you need medical quality parts with all of the benefits of our Supermold:


Get into production quicker and for a smaller investment up front

Go from purchase order to first article in 10 days with SuperMold™

 

When you 3D print you are spending prototype dollars. Money that will never translate to production budgets.

 

SUPERMOLD accelerates your timeline by using your prototype dollars on making a production mold designed to take advantage of production efficiencies.

SUPERMOLD uses 103 tool steel to provide a production mold that is guaranteed for as long as you need parts. Our full tool shop allows quick turnaround to put parts in your hand when needed, at a cost effective price point.

 

Reduce costs and lead times for custom injection molds to process thermoplastic or metal components.

 

SuperMold ISO13485 quality validation: $4300

30 nominal samples to customer

Manufacturing Process Characterization

1-piece Full FAI Excluding GD&T

30-piece Capability Study of 3 Critical Dimensions (Variable Method; Gauge Pin, micrometer, etc)

Validation Summary Report


In addition:

  1. Tooling Design Records Retained at ASH

  2. Design for Manufacturing Review Records

  3. ASH Process Flow Documentation

  4. ASH Process FMEA

  5. Control Plan

  6. 1-piece Full FAI Excluding GD&T

  7. 30-piece Capability Study of 3 Critical Dimensions

  8. Raw Material COA

  9. Process Parameter Report Including Low, High, and Nominal Settings

  10. Calibration Certifications

  11. 30 Nominal Samples Provided to Customer for Analysis

  12. Master Retain Preserved at ASH

  13. Certificate of Conformance

  14. Validation Summary Report

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