All medical consumables supplied by Swissina Health meet the applicable European requirements for medical devices and personal protective equipment.
Our products carry the CE mark and thus meet the essential requirements of the European Medical Device Regulation (MDR) and the PPE Regulation. Certificates and declarations of conformity are provided on request.
Our suppliers work according to the internationally recognised ISO 13485 quality management system for medical devices, which defines consistent requirements for design, manufacturing and distribution.
We keep the relevant declaration of conformity on file for every product category. Institutional customers receive these documents together with their quote or on request for their internal procurement documentation.
For internal quality assurance at hospitals, clinics and pharmacies, procurement departments often need product-specific evidence. We are happy to compile CE certificates, our suppliers’ ISO 13485 evidence and declarations of conformity by product — just tell us which items you need and we’ll send you the relevant documentation.