Full service Contract Manufacturing for integrated devices

All Contract Manufacturing processes for medical devices are carried out in accordance with UNI EN CEI 13485:2016 standard and on the basis of proven experience in the field of integrated devices. A multidisciplinary team assists the customer in design, industrialisation, methods, assurance, quality and regulatory affairs. The manufacturing process is validated with DQ/IQ/OQ/PQ methodology, according to GMP guidelines.

The main technological services are:

  • Mechanical design.
  • HW and SW electronic design.
  • Engineering and process development for manufacturing or assembling medical electrical Equipment and Devices.
  • Manual and automated assembly of different plastic components, for example, of the microfluidic type, also through the use of different welding technologies, such as laser welding and ultrasonic welding.
  • Mechanical, electrical and pneumatic tests on components and finished product.
  • ISO 7 clean room moulding. – Design and construction of moulds for injection moulding of thermoplastic polymers.
  • Assembly of SMT/THT electronic components, and Die Attach and Wire Bonding microelectronics.
  • Chip & Wire, Die Attach and Wire Bonding of microelectronics components.
  • Analytical controls such as X-ray, SEM microscopy, IR spectrometry, TGA thermogravimetry and DSC differential scanning calorimetry.
  • Packaging by heat sealing and management of the external sterilization process.
  • Production under the “DNA/RNA/DNase, RNase free” regime particularly for in-vitro diagnostic applications.
Some examples:
  • Manufacture (assembly and testing) of IVD medical electrical equipment for use in Point of Care (PoC) analysis
  • Manufacture (assembly and testing) of IVD medical electrical equipment, including the laboratory research and analysis disposables thereof
  • Moulding and assembly of disposable components or devices for the IVD field.