Milan, a global powerhouse in biotechnology and advanced manufacturing, demands electronics that meet stringent EU medical device directives (MDR). As an ISO 13485 certified partner, we bridge the gap between high-efficiency Chinese manufacturing and the rigorous quality requirements of Lombardy’s healthcare sector. Whether it is diagnostic equipment for Niguarda Hospital or portable wellness devices developed by Milanese startups, our PCBA solutions provide the precision, clean-room assembly, and traceability required for Class II and Class III medical devices.
We provide a "glocal" approach: the rapid prototyping and cost-efficiency of our Shenzhen facilities combined with the technical oversight required for European certifications. Our supply chain management ensures that even in volatile global markets, component sourcing for critical medical applications—such as life-support monitors—remains continuous and compliant with RoHS/REACH standards.
A: Yes, our factory operates under ISO 13485. We assist clients by providing full material traceability (BOM level) and test reports necessary for your CE marking process.
A: We specialize in NPI (New Product Introduction). There is no minimum order quantity (MOQ) requirement, making us an ideal partner for the vibrant R&D ecosystem in Milan.
