DSC06605_JCTotal Outsourced Manufacturing Solution

Smithstown provide supply chain solutions to customers where quality is a priority. We offer our partners a total outsource solution with quality systems underpinning our extensive manufacturing capabilities. Our commitment to quality is seen in our record of continuous investment in our quality systems.  We have implemented ISO9001 (Quality), ISO13485 (Medical Devices) and ISO14001 (Environmental Standard) and have integrated Six Sigma and Lean principles in all that we do.

These quality systems ensure that we offer a controlled and efficient service to our partners. This is confirmed by an independent accreditation body. We currently manufacture a range of medical devices for several customers in mid-to-high volumes on a kanban basis. Such projects have been built on our quality systems.

Smithtown’s contract manufacturing offering includes:

  • Project Management;
  • Product Development and Design;
  • Inventory Management (Raw Materials, Components and Finished Goods);
  • Supply Chain Management, including Supplier Identification, Qualification, Audits and Performance Monitoring;
  • Product/Process validation incorporating PSW/PPAP supplier controls, Process Maps, Risk Analysis, Gauge R&R, CPKs, PPKs , Machine IQ/OQs;
  • MiniTab Statistical Analysis;
  • Process Development and Validation;
  • World Class extensive manufacturing capabilities all in one plant (total outsource solution);
  • Onsite heat treatment;
  • Surface Passivation;
  • Packaging (Sterile and Non- Sterile);
  • Product labeling for identification and traceability.

Subcontract Machining – CNC Milling and Turning, Wire and spark EDM, CNC Grinding, OD/IS/Centreless Grinding, Laser cutting and more

Contact machining colutionsSmithstown UK provide a complete subcontract machining service throughout the UK.   All of our listed capabilities are all located under one roof, giving us total control of our processes. This allows Smithstown to offer our customers the opportunity to consolidate a multi supplier process into a single supplier validated manufacturing process. Our subcontract machining services include:

Examples of current contract manufacturing projects include:

  • Medical bone saw components -high volume project,
  • Precision component for a transcatheter aortic valve implantation delivery system -high volume project
  • Medical Orthopaedic Instrumentation -batch quantities
  • Supplying wax parts from our wax moulding machine, used in the Lost Wax Investment Casting process at customer plant in the production of knee replacement implants – medium volume kanban agreement with our customer.
  • Precision turned parts produced in high volume on our Citizen lathe, used in stent delivery system – this is a highly automated process, lights out manufacturing = low cost.

We have invested significant resources in ensuring our equipment and facilities exceed the requirements set to manufacture medical devices. Machine IQ/OQs, calibrations, quality systems ensuring traceability and control in method of manufacture.