Co-Manufacturing

Move from a validated design to units you can sell. Design transfer, tooling, pilot batches and larger-scale assembly at our audited site, with complaint handling and device history records in place from the first build.

Design transfer

The point where a design becomes a repeatable build. Drawings and tolerances become work instructions, tooling and inspection checks an operator can follow.

Pilot & small-batch

Enough real units for a clinical evaluation, a regulatory batch or a first sale, built to production records without committing to hard tooling.

Larger-scale assembly

Volume assembly on our own audited lines in Navi Mumbai, with batch records, traceability and release testing on every build.

Sterile & assembly support

Getting the device to the patient sterile: the barrier that has to survive the process, the sterilisation route it can take, and the validation that proves it.

Post-market support

What has to keep running once the device is sold. Complaints are recorded, investigated and closed, and what they reveal feeds the next build.

01
Transfer the design
Outputs checked as fit for production, with tooling and work instructions.
02
Build a pilot
Units made the way production will make them, to find the problems early.
03
Validate and release
Processes validated where the output cannot be fully checked afterwards.
04
Produce and support
Batch records, traceability and complaint handling from the first build.