The Ukrainian manufacturer, situated in Kyiv, is looking for company who, under outsourcing agreement, will help to prolong ISO 13485/CE certificate for medical devices.
The company has its own production of medical thread.
The company manufacturing line has a comprehensive quality management system in line with implemented ISO 13485 which meets all modern requirements in terms of quality, safety and international requirements for clean rooms.
The main company products is thread made of 100% polymer. This thread is softer than silk, prevents the contamination with microorganisms thanks to it structure, absolutely inert, has high tensile strength and high knot security, it's easily to handle, and havenít got a package memory.
The company is looking for the partner who could help to the company to obtain the prolongation of the ISO 13485 certification.
Company wishes to work under the outsourcing agreement.
- Type of partner sought: The company is looking for an accredited Notified Board specializing in medical devices that would assist in obtaining prolongation of the ISO 13485/CE certification.
- Specific area of activity of the partner: The desirable type of partner should be the organization experienced in the certification of the medical devices.
The potential partner should help the company in obtaining the prolongation of the mentioned certification.
- The thread structure density prevents bacterial contamination.
- All thread are made of inert and unreactive material
- The thread are soft and very comfortable for patient.
Company has an in-house Quality Control Laboratory with a validated Ethylene oxide (ETO) sterilization system.
Due to the own production, company is ready to develop and manufacture atraumatic medical threads on an individual request, taking into account client wishes.