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How to choose a medical injection moulding partner
The useful questions are about where the tool is made, where a correction happens, and what the certificates actually cover.
Ask first whether the moulder builds its own tools. Where the tool comes from a separate supplier, every dimensional correction becomes a negotiation between two companies with the programme waiting. Where tool and moulding sit in one plant, a correction is an internal decision measured in days.
Ask second what the certification covers. ISO 13485:2016 is the medical device quality standard and ISO 9001:2015 is the general one; holding both is normal for this work. What matters is the scope statement on the certificate, because a certificate can cover a process that is not the process making your part.
Ask third about validation. Volume production from a validated tool is a different commitment from first-article approval, and a supplier that talks only about samples has not addressed how the thousandth part will resemble the first.
Specifications
| First question | Does the moulder build its own tools? |
|---|---|
| Second | What does the certificate's scope actually cover? |
| Third | How is volume production validated, not just first article? |
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Material selection for moulded medical parts
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Send us a drawing and we will tell you what it will cost to tool
Send the 3D data or the drawing with the annual volume and the material. You will get a tooling cost, a sampling schedule and an opinion on anything in the design that will be difficult to mould.