WORKING WITH US

Custom made products ask for differentiated approaches and customized advice. At AMM we take into consideration the part geometry, material considerations and tool layout that is appropriate to the injection molding technique and to the optimum cost effectiveness for injection molding. Our experienced team is looking forward to meet your challenges. 

The smallest of dimensions, narrowest of tolerances and highest functional demands are requirements that we understand due to the experiences we have gathered over many years. 

Qualifying a mold and validating the molding process in the medical device (FDA requirements) typically requires that the validation process be performed in a specific molding machine that will also be used in production with a specific process. Usually that means that the tool shop first qualifies the mold at their place or at an outside molding shop.

After the mold checks out, it is shipped to American Medical Molding where we will perform a mold qualification and process validation. This is because proper validation that conforms to FDA standards requires that the mold be validated in the press in which it will run.

After a mold is functionally operational and capable of making the part for which it was designed and built, the validation process begins, typically with the keys to the molding process: mold, press, tolerances, metrology and geometrical dimensioning and tolerancing (GD&T).

Validation is typically defined by a dimensional report that includes the molding process itself. Documentation is recorded as to how the process was developed and proof that the process is capable of re-producing parts repeatably and consistently to the specifications. Fully documented dimensional and part process-related results satisfy the criteria that is typically outlined in any master validation plan.