ISO CERTIFICATION FOR MEDICAL DEVICES

ISO 13485:2016 Quality Management System

The globally recognized standard ISO 13485, published by the International Standards Organization, represents the regulatory requirements for a comprehensive quality management system for the design and manufacture of medical devices.

  • The company was awarded the certification ISO 13485 Quality Management System for Medical Devices in 2011.
  • The TIES System received CE marking in June 2016. To meet the added requirements under the new European Medical Device Regulation (MDR), an extended clinical study with up to 200 patients is ongoing to gather more data on performance, usability, quality of life and health economics.
  • The TIES Solution is the result of several years of research combined with the latest 3D manufacturing technology. It has been developed and manufactured in accordance with regulatory standards to ensure patient safety..
  • OstomyCure addresses a market estimated at USD 2 billion per year.

PLEASE CONTACT US FOR AVAILABLE DOCUMENTATION

Why Choose OstomyCure

It is the people who make OstomyCure what it is and we are extremely proud of the achievements of our staff.
We all work together to help our patients through recovery, providing ground breaking ileostomy medical solutions.

  • Improved health economics

    It is estimated that stoma patients spend more than EUR 3000 a year on stoma bags and other consumables.

  • No leakage, odours or accidents

    The TIES Lid seals the evacuation system, with a hatch that you can open and close to empty the stoma.

  • No permanent ostomy bag

    No permanent bag means reduced risk of skin irritation, infections and other inconveniences.

  • Improved QoL

    Aim to give patients their quality of life back using the latest technology, with no compromises on quality or safety.

  • Minimised risk of hernia

    Initial usage from our extensive clinical studies showed reduced parastomal herniation.

  • A simpler life

    The ground breaking TIES Ileostomy system helps stoma patients take back control and live a more carefree life.

WHAT OUR MANAGEMENT TEAM
& PATIENTS ARE SAYING