Medical Device Manufacture

Sovrin specialises in the development and manufacture of mould tools, plastic injection moulded components and the assembly of complex devices for the pharmaceutical, drug delivery, medical, and healthcare industries. Our engineering expertise developed over thirty years serving these markets and the latest technology ensure consistent and superior quality is invested in all we produce.

Capabilities

  • Over 30 years of expereince manufacturring plastic medical devices
  • Precision injection moulding
  • Class 7 & 8 Cleanrooms, Whiteroom areas & Customer specific manufacturing cells
  • Automated & hand assembly and value added operations
  • Customer specific medical device manufacturing cells
  • Clincal trial builds
  • Validation & qualification
  • ISO13485, FDA compliant
  • Regulatory affairs management
  • Support in the preparation of Design & Drug Master Files
  • Bioburden management

Healthcare applications

  • Drug delivery systems
  • Diagnostics & Patient monitoring
  • Ophthalmic devices
  • Surgical instruments
  • Implantable medical devices
  • Microfluidics

Sovrin recognises the needs of our customers in the design, manufacture, validation and qualification of all processes, facilities and equipment ensuring compliance with international and regulatory standards (e.g. FDA & MRHA).