Medical Device Industry

Scope and process

Our integrated engineering department collaborates directly with medical device industry procurement and engineering teams: (1) 2D/3D CAD drawing review and material selection; (2) In-house mould and fixture toolroom fabrication; (3) Multi-axis CNC machining and high-tonnage hydraulic preforming; and (4) 100% batch metrology verification with full Material Test Reports (MTR). For our complete range of capabilities, explore our OEM & ODM custom manufacturing solutions (/custom-manufacturing).

Materials we work with

Components for medical device industry applications are produced from premium virgin and filled polymers (15–25% glass-filled, 25–33% carbon-filled, 40–60% bronze-filled, MoS2, PEEK, Delrin POM-C, UHMWPE, and technical ceramics). Raw resins are strictly tested for density (ASTM D792) and tensile strength (ASTM D4894) with batch traceability maintained for all production runs.

Tooling support

Tooling is finished for crevice-free geometry, since cleanability governs the customer’s device validation.

Choosing the right option

To request an OEM/ODM proposal for medical device industry parts or machinery, submit 2D PDF technical drawings or 3D STEP models, material requirements, annual batch quantities, and operating pressure/temperature parameters. Our engineering department provides comprehensive technical and commercial proposals within 24 hours.

Quality checks and inspection

Inspection focuses on dimensional repeatability and surface finish, with the resin lot recorded for the device history file. Dimensions are verified on CMM against the drawing and sintered density checked per ASTM D792; a mill test certificate accompanies each despatch.

Commissioning and handover

For machinery deliveries (Precision PTFE Compression Presses, Custom Engineered Hydraulic Presses), HEMSUN provides complete factory acceptance testing (FAT) at Dahegam prior to shipment, followed by on-site foundation anchoring, electrical cabling, hydraulic oil charging, and operator training by factory service engineers.

Export packing and lead time

Parts ship individually bagged with material documentation suitable for inclusion in a device file. HEMSUN is a DGFT IEC registered exporter (Government of India); commercial invoice, packing list and certificate of origin accompany international despatch.

Maintenance and spare parts

Components are replaced on a validated schedule rather than on condition. HEMSUN has not yet delivered a completed programme in this sector; the capability described here is engineering capacity we can apply, not a record of past supply.

Specifications