In-Vitro Diagnostic (IVD)
We are your experience manufacturing partner for the in-vitro diagnostics (IVD) industry, supporting medical and life science companies with tooling, precision injection molding, assembly, reagent handling processes and sterilization.
We produce consumables used in diagnostic cartridges, sample handling systems, microfluidic devices, test housings, and point-of-care diagnostic products. Our capabilities support both disposable and semi-disposable IVD components produced at scale. Our capabilities also include manual, semi and fully auto aliquoting of reagents and controlled dispensing into cartridges & tubes & complete it by labelling supporting both disposable and semi-disposable IVD applications.
With an IVD certified under our ISO 13485 aligning our quality system we help IVD companies move efficiently from development to high-volume production while meeting global regulatory and performance requirements. These products are designed to meet stringent requirements for accuracy, repeatability, cleanliness, and reliability.
Case Study
We have designed and manufactured automated immunoassay analyzers used in hospital laboratories for the quantification of cardiac biomarkers. Our experience also includes diagnostic cartridges, sample handling systems, microfluidic devices, test housings, and point-of-care diagnostic products. We support both disposable and semi-disposable IVD components produced at scale.
Together with our customers, we implement comprehensive design controls, performance verification, and stability studies, supported by ongoing post-market surveillance to monitor field performance and adverse event data in accordance with ISO 13485 requirements. Our responsibility to customers extends beyond manufacturing to full lifecycle support.
Take Your Medical Device to the Next Stage
Whether you’re refining a concept or transferring production, Racer Medical provides the expertise to scale with confidence.