Genemed has 20 years of expertise in IVD Reagent manufacturing. Outsource your IVD manufacturing to us so that you can focus on new product development. Genemed will assist in product format, stability, distribution process, batch size, reproducibility, and production of your product. We understand that with patient samples, you only have once chance to make a reliable diagnosis. Let us shorten your product time-to-market and decrease your start-up costs.
Genemed has a GMP-compliant and ISO 13485 certified facility. Genemed has material flow control, personal flow control, and campaign-style manufacturing which help create robust, consistent, and reproducible products for you. Genemed has the facilities, certifications, and processes in place including multiple clean rooms and dedicated equipment as required for every product manufactured, as well as extensive cleaning and monitoring of equipment. Process controls help to prevent mix-ups, while documentation and identification provide for traceability. Our process validation tests for extreme parameters to ensure a robust and reproducible manufacturing process.
Genemed’s IVD reagent manufacturing service includes formulation, testing, filling, label control, inspection, packaging and shipping.