From pilot manufacturing of components, complex sub-assemblies and full devices, right up to supplying packaged and sealed products from our cleanroom in commercial volume production.

Quality at ICS

At ICS we have a strict Quality Management System (QMS) in place to cover all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labelling, packaging and more.

ICS Medical Devices, Catheter Manufacture and design

ISO 13485 Certification

Our QMS is ISO13485 certified, ensuring that our customers’ requirements are fulfilled in a collaborative way to the highest of standards. ISO 13485 is an international quality management system standard followed by companies operating in Europe, Canada, Australia, and other markets.

ICS Quality Capabilities

ICS Medical Devices' Quality professionals have extensive knowledge in the application of standards across medical device development and manufacturing, and we have broad experience in product design including design control and design assurance for medical devices.

ICS Quality Capabilities

  • Product control and traceability through the design, development and manufacturing stages.
  • Problem solving and root causing, data-led decision making from early design through manufacturing stage of the product lifecycle.
  • Cleanroom and microbiological controls.
    Sterile packaging seal and packaging labelling.
  • Validations including IQ, OQ, PQ, PPQ, TestMethod development and TMV’s.
  • Design assurance and design control experience including design test strategies, Design Verification & Validation supporting our customer product approvals.
  • Risk management including DFMEA, PFMEA, Hazard Analysis etc.
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Find us

ICS Medical Devices is based in Galway, Ireland’s Medical device hub, so we’re centrally located to serve the medical device industry globally.

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