In June 2018. after one-year google promotion on plastic injection molding molds. we thankfully got a new inquiry for plastic housings and components for medical equipment from one of the leading medical device manufacturing companies in the US.
The first case we discussed is for small parts which used as disposable parts in medical devices, and we help to support analysis for the feasibility of manufacturing. and reports completion in a short time, the client engineering team was quite impressed with the job ours . after a round of improved actions taken on design base on our professional proposals, we were patient to answer all doubt that the client may have. in the end, the US client decided to go with us for this project.
In June 2018. the FOT ( first of trial ) was done and samples were inspected well, reports were ready to be sent to the engineering team of clients. we successfully got approval on geometric from them on their test of material certification and assembly condition. So the FAI we did was great as always to any other customers from the EU and US.
Then we move ahead to have designated texture according to the industrial standard as we advised the client about cosmetic expectations. Our expertise moved the US engineering team to the final release for tooling .and we got great feedback from our rapid support.
In the pilot run phase, we were required to produce 200 sets so that the US team can have them try their new production line in Mexico. with providing all processes documents and validation reports summarized. this pilot run can test the mold that we made to be the one for mass production without poor CPK. in fact, we passed it and smoothly reach the final stage.
In total, the US team was quite happy with our efforts and promise to have further case cooperation, and send a team to have an official audit of our factory and the system that we use.
In Jan 2019, after projects work, and strengthening our status in the US client’s system, we have the pleasure to have a visit of US team, in the overall processes audit, we had some feedback of improved actions to be taken, overall status can meet and reach the expectation of US team. we are an ISO13485 company in production with a strong ability to make high-quality injection molding molds which makes us have this client as long-term relations.