A Sourcing Checklist for Medical Device Precision Parts

What this page covers

• Material: confirm stainless steel, titanium, PEEK, medical-grade silicone or ceramic as the drawing requires
• Process: confirm CNC machining, moulding, liquid silicone moulding or precision grinding as the feature requires
• Inspection: confirm coordinate measuring machine, projector and height gauge checks, and whether a dimension report will be provided
• Quality system: confirm the stated ISO 13485 medical device quality management certification, valid until 2028-04-15, with no certificate number or issuing body stated here

What to confirm before ordering

No customer name or case is claimed on this checklist, because no customer is named in the evidence. A supplier that names customers it cannot evidence should be treated with caution. Before ordering, confirm minimum order quantity and lead time for your drawings.

Drawing checklist

Send the drawing with units and scale stated, the material and grade, the critical dimensions and tolerances marked, and the finish required. State the quantity you need checked and the question the part must answer: fit, function or appearance. Uploaded files are used only for the quotation, and non-disclosure agreements are supported.

Quality checks

Parts are inspected with a coordinate measuring machine, a projector and height gauges, with quality control at each production stage, and a dimension report can be provided for a project on request.