Randox is the most flexible OEM company in the world and has been supplying many of the world's top diagnostic companies for years. We are the diagnostic manufacturer's one-stop OEM/contract manufacturing service provider.
With over 30 years experience in manufacturing diagnostic products, we understand the needs and challenges of manufacturing and the customised packaging requirements for high quality products that support the global IVD market.
Randox key OEM capabilities:
Building on our 30 years experience and expertise in diagnostic and quality control kit manufacture has enabled us to become a world leader in manufacturing reagents and quality controls.
All products are manufactured in our state-of-the-art ISO 13485 certified facilities including fully equipped laboratories for production, quality control, product development and R&D.
• Raw material sourcing from an inventory of over 100,000 products
• Liquid batching and filling
• Life science production
• Method development and product characterisation
• Large lyophilisation capacity (up to 250,000 vials)
• Method validation
Randox adheres to a strict quality system, ensuring all our processes are of the highest quality.
• Consistency -- managed through product improvements and change control
• Quality assurance -- quality services moulded to your individual needs
• Traceability -- documentation available
• Communication -- open and honest communication with customers
• Regulatory expertise and registrations for medical device manufacturing
• Process control for each aspect of manufacturing and customer support
• Audit availability
• Change control notification
