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Medical custom OEM ODM injection molding faster lead time

moulded under ISO 13485:2016 with lot traceability from resin batch to finished part and controlled change management on any tool modification.

Medical custom OEM ODM injection molding faster lead time

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Product Overview Specifications Related Custom Services

Product Overview

We mould medical device housings and fluidic components under ISO 13485:2016, so the process controls, the documentation and the change management follow a medical quality system rather than a general engineering one.

Medical parts are usually small, often thin-walled, and almost always appearance-critical, so the mould has to be built for the surface as much as for the dimension. We specify the cavity steel for the finish you need and vent the tool so thin sections fill without burning.

Quality system

  • ISO 13485:2016 alongside ISO 9001:2015 and IATF 16949:2016
  • Lot traceability from resin batch to finished part
  • Change control on any tool or material modification
  • Clean handling and packing to the agreed standard

Typical parts

  • Device housings, enclosures and covers
  • Fluidic components, luer fittings and valve bodies
  • Syringe and dispenser components
  • Surgical instrument handles and overmoulded grips

Material is selected to your drawing. The grades listed are the ones we run most often for this type of part; we confirm the choice at DFM rather than assuming it.

Specifications

ParameterValue
ApplicationMedical device housings, fluidic components and instrument parts
MaterialSelected to your drawing. We run PC, PC/ABS, ABS, PMMA, PPSU, PEI, PEEK, TPU and silicone LSR for this kind of part and confirm the grade with you at DFM.
Wall thickness0.8–3.0 mm typical; thin-wall capability on high-speed machines
Tolerance±0.05 mm typical, ±0.01 mm on precision features
Surface finishHigh gloss, SPI standard texture, moulded or machined datums
Cavity steelS136 (HRC 50±2) for mirror and acid resistance; NAK80 for texture
CleanlinessClean handling, controlled packing and lot traceability
Tool life500,000–1,000,000 shots on hardened inserts
DocumentationLot traceability, material certificate and change control records
CertificationISO 13485:2016, ISO 9001:2015, IATF 16949:2016

Related Custom Services

  • Overmolding of soft-touch grips and seals onto the housing
  • Insert molding of metal components and threaded inserts
  • CNC machining of sample parts before the production tool is cut
  • Laser engraving of part numbers, lot codes and 2D data matrix codes

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Product Overview

Product Overview

We mould medical device housings and fluidic components under ISO 13485:2016, so the process controls, the documentation and the change management follow a medical quality system rather than a general engineering one.

Medical parts are usually small, often thin-walled, and almost always appearance-critical, so the mould has to be built for the surface as much as for the dimension. We specify the cavity steel for the finish you need and vent the tool so thin sections fill without burning.

Quality system

  • ISO 13485:2016 alongside ISO 9001:2015 and IATF 16949:2016
  • Lot traceability from resin batch to finished part
  • Change control on any tool or material modification
  • Clean handling and packing to the agreed standard

Typical parts

  • Device housings, enclosures and covers
  • Fluidic components, luer fittings and valve bodies
  • Syringe and dispenser components
  • Surgical instrument handles and overmoulded grips

Material is selected to your drawing. The grades listed are the ones we run most often for this type of part; we confirm the choice at DFM rather than assuming it.

Specifications

Specifications

ParameterValue
ApplicationMedical device housings, fluidic components and instrument parts
MaterialSelected to your drawing. We run PC, PC/ABS, ABS, PMMA, PPSU, PEI, PEEK, TPU and silicone LSR for this kind of part and confirm the grade with you at DFM.
Wall thickness0.8–3.0 mm typical; thin-wall capability on high-speed machines
Tolerance±0.05 mm typical, ±0.01 mm on precision features
Surface finishHigh gloss, SPI standard texture, moulded or machined datums
Cavity steelS136 (HRC 50±2) for mirror and acid resistance; NAK80 for texture
CleanlinessClean handling, controlled packing and lot traceability
Tool life500,000–1,000,000 shots on hardened inserts
DocumentationLot traceability, material certificate and change control records
CertificationISO 13485:2016, ISO 9001:2015, IATF 16949:2016
Related Custom Services

Related Custom Services

  • Overmolding of soft-touch grips and seals onto the housing
  • Insert molding of metal components and threaded inserts
  • CNC machining of sample parts before the production tool is cut
  • Laser engraving of part numbers, lot codes and 2D data matrix codes
Medical custom OEM ODM injection molding faster lead time
moulded under ISO 13485:2016 with lot traceability from resin batch to finished part and controlled change management on any tool modification.
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