Original Equipment
Manufacturer service (OEM)
Established in 2012, Medical Innovation Ventures Sdn. Bhd. (MEDIVEN) has become a pioneer in Malaysia’s real-time PCR manufacturing landscape. With over a decade of experience and an unwavering commitment to quality, we stand as your reliable partner for molecular diagnostic and lateral flow assay contract manufacturing. Our end-to-end services, from research and development to commercialization, are designed to be flexible, scalable, and fully supported by our regulatory expertise, ensuring your products meet the strictest international standards and accelerate your market entry.
Molecular Diagnostic
Contract Manufacturing Services
End-to-End Solutions
We offer comprehensive OEM and contract manufacturing services, providing a seamless journey from R&D to commercialization. Our facility's flexibility, scalability, and full regulatory support are key to a faster market launch.
Rigorous Quality Control
We utilize cutting-edge real-time PCR systems, including Bio-Rad CFX, Thermo Fisher QuantStudio 5, Bioer LineGene, and Rotor-Gene, to perform stringent quality control and batch testing.
Flexible Manufacturing Options
We accommodate various formats, from bulk reagents to full kit assembly and OEM/white-label packaging. Our assembly options range from manual for small batches to fully automated liquid handling for high-throughput scalability.
Customized Additional Services
Our services extend beyond core manufacturing to include feasibility studies, pilot-scale runs, custom reagent mixing, aliquoting, and repackaging tailored for different geographies. We also provide cold-chain logistics, global shipping, and technical documentation preparation (COA, SDS, IFU).
Lateral Flow Assay Contract Development And Manufacturing Services
Dedicated Expertise:
- As a leading lateral flow assay manufacturer in Malaysia, our team of expert scientists provides deep knowledge and experience in lateral flow development.
Comprehensive CDMO Services:
- We offer a full suite of Contract Development and Manufacturing Services (CDMO), covering everything from initial assay development and prototyping to technical transfer, manufacturing, and clinical validation.
Key Advantages:
- Outsourcing to MEDIVEN gives you access to automated and flexible manufacturing lines, an ISO 13485-certified quality system, capacity for rapid scale-up, and a reliable, well-vetted supply chain.
Broad Capabilities:
- Our manufacturing capabilities are robust, featuring BioDot dispensing and lamination systems, a Class 100k cleanroom, and a mix of manual and semi-automated lines to handle all volume requirements.
