• EN ISO 13485 scope certifies Qualtech for the sub-assembly manufacture, assembly and system integration of non-invasive Medical Devices such as PCBA’s, Muscle Stimulants and Respiratory products. It also covers Supply Chain Management including Procurement, Materials Management, Pick/Pack/Ship and Customer Order Fullfilment.
  • Qualified sub-contractor for FDA approved medical devices.
  • Capability in Sub-Assembly to Finished Product including in-house manufacture of Cables, PCBA and Unit Assembly in addition to purchased materials.
  • Product and Component traceability to required customer and ISO standards.
  • Products include Respirators, Ventilators, Nebulisers and Muscle Stimulants.