09/03/2026
When a client needed to scale an IVD device for detecting serious bacterial infections, we didn’t just automate a pilot process — we engineered the product for manufacture and assembly from the outset.
Through Design for Manufacture (DfM) and Design for Assembly (DfA), our NPI team transformed a lab-based concept into a robust, repeatable industrial process.
The solution: a 23-station fully automated assembly system incorporating laser processing, load cell verification, advanced vision inspection and 100% functional testing — operating within an ISO 7 cleanroom environment.
From Design Qualification (DQ) and Factory Acceptance Testing (FAT) through to OQ and PQ validation, the project delivered not just automation — but a fully validated, scalable manufacturing platform.
The result is a seamless transition from a lab-based concept to a fully automated industrial solution.
Take a look at our page for the full case study: https://bit.ly/4kP9wnJ
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In Vitro Diagnostic (IVD) device From the laboratory to the factory When selecting a Contract Manufacturing Organisation (CMO), careful consideration must be given to the technical capability of the organisation to support the Medical Device OEM throughout the life cycle of the project. Sovrin as...
