Service 04
Manufacturing & Launch
Getting from a verified design to validated, repeatable production — and supporting the first units into clinicians' hands.
Design transfer
- Manufacturing process design, work instructions and inspection plans.
- Supplier selection and qualification for PCBs, mouldings, packaging and sterilisation.
- Pilot builds and first-article inspection.
Validation
- Process validation (IQ / OQ / PQ) and test-method validation.
- Packaging and shelf-life studies, sterilisation validation.
- Design validation with real users in the intended environment.
Launch and beyond
- Production release, labelling and UDI, distribution set-up.
- Clinical training material and early-user support.
- Post-market surveillance, complaint handling and design changes.