Quality & Certifications
We manufacture under an ISO 13485 quality management system, with CE marking, ISO 10993 biocompatibility and validated ethylene-oxide sterilization. We provide all the documentation you need for registration and tenders.
ISO 13485:2016
Quality management system specific to medical devices. It governs our whole process, from design to packaging and traceability.
CE Mark — MDR 2017/745
Conformity with the European Medical Device Regulation (MDR), required to market in the European Union.
ISO 10993 biocompatibility
Biocompatibility testing of patient-contact materials: cytotoxicity, irritation and sensitization.
EO sterilization
Validated ethylene-oxide (EO/ETO) sterilization for circuits, catheters and kits, with an indicator on every individual pack.
Lot traceability
Every batch carries a lot number and date; we keep production and QC records for audits and tenders.
In-house manufacturing
Production in our own facility with cleanroom. Control from raw material (medical PVC, latex-free) to the finished product.
Quality control, step by step
- Incoming raw-material inspection (medical PVC, connectors, latex-free and DEHP-free materials on request)
- In-process control: dimensions, sealing, tube and connection integrity
- Product-specific functionality testing (leak-tightness, flow, balloon pressure, suction)
- Sterility verification and EO sterilization indicator per lot
- Final sampling inspection (AQL) before packaging and dispatch
- Retention samples and lot records kept on file
Documentation we provide
- ISO 13485 certificate
- CE certificate / Declaration of Conformity
- ISO 10993 biocompatibility report
- EO sterilization validation report
- Product technical data sheet
- Manufacturer's letter and Free Sale Certificate (CFS) on request
Quality — Frequently asked questions
Do you provide the certificates for my country's registration?
Yes. We provide the document package (ISO 13485, CE, ISO 10993, EO sterilization report, data sheets and manufacturer's letter) — the documentation requested by COFEPRIS (Mexico), INVIMA (Colombia), ANMAT (Argentina), DIGEMID (Peru), ISP (Chile) and equivalent agencies.
Are products latex-free and DEHP-free?
Our products are made of latex-free medical PVC. For lines in contact with lipids or neonatal/paediatric use we offer DEHP-free versions on request. Tell us the application and we'll confirm the right version.
How are the products sterilized?
Sterile products are sterilized by ethylene oxide (EO), the standard method for heat-sensitive devices such as breathing circuits, catheters and kits. Every individual pack carries a sterilization indicator and validation is documented per lot.
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