SP Meditec

SP Meditec is an ISO 13485 certified contract manufacturer specializing in precision plastic components and assemblies for medical device OEMs. The company provides end-to-end services from product design and development through injection moulding, automation, and cleanroom assembly. With facilities across Denmark (Helsingør, Karise), the USA (Peachtree City), and Poland (Zduńska Wola), SP Meditec supports regulated medical device development with design-for-manufacturing expertise, validated processes, and comprehensive regulatory documentation support. Their service portfolio includes human-factored design, systems engineering, mechanical design, risk management, tooling engineering, process automation, and test engineering. The company maintains ISO 13485, ISO 14001, and ISO 45001 certifications and emphasizes reliable lead times, cost mitigation, and accelerated time-to-market for medical device manufacturers.