We Manufacture & Export Advanced Medical Devices

Why Türkiye, Why SKY Biotechnology?

SKY Biotechnology manufactures its own portfolio at its own facility in Pendik, Istanbul. Türkiye sits where the European and Middle Eastern supply routes meet, which brings short lead times and competitive production costs; what makes that useful is pairing it with European quality infrastructure under the same roof. Our facility operates an ISO 13485 certified quality management system, with Class 100, Class 1000 and Class 10000 cleanroom areas, and our portfolio is CE marked. Development, formulation and product-safety studies are run by our own engineering team, so custom packaging, volume and labelling requests are answered without waiting on an outside supplier. Ten years of uninterrupted manufacturing and export, more than fifty active markets and over a thousand hospitals served mean the dossier and the labelling have been tested before you receive them.

For distributors: what an in-house, CE-documented manufacturer changes

In the European market, sourcing from a manufacturer that holds its own CE documentation is no longer a preference but a commercial threshold. As certification requirements have tightened, suppliers who outsource production have contracted their portfolios, and distributors working with them lose control of batch continuity and delivery schedules; a stock-out costs a clinical account that took months to win. Because manufacturing, quality management and regulatory affairs sit under one roof here, the batch plan and the delivery schedule can be committed, and the technical file and CE documentation come from the same place as the product rather than arriving late from a third party. Commercially, direct sourcing leaves the intermediary margin with the distributor, four product families can be carried under one contract with one quality record and one logistics line, and a documentation pack that is ready for tender review removes the risk of being disqualified on missing evidence. Regional exclusivity, volume commitment and commercial terms are open to negotiation.