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.