Continually improve your business with the international standard on medical devices
ISO 13485 is an internationally recognized standard, first adopted in 1996, and refers to the requirements of a quality management system for the manufacture of medical devices. The latest version of this standard, offered by our company, was adopted on March 1, 2016.
Although often implemented independently of other standards, ISO 13485 is essentially fully aligned with the ISO 9001 quality management system and demonstrates the commitment of the manufacturer to the maximum correctness and quality of its medical devices.
ISO 13485 brings many benefits to any firm or organization that decides to implement this standard into its business, and some of these benefits are:
- Increase in placements on world markets;
- Improving the way of reviewing and improving the process in the organization;
- Increase efficiency, reduce costs and monitor the efficiency of the supply chain;
- Increasing production and sales of safer and more effective medical devices;
- Fulfillment of legal regulations and customer expectations.
Regardless of whether you are still considering implementing the ISO 13485 standard or have already started this process, our company can help you complete it quickly and easily.
Just select the phase in which you are and start already today with creating a better future for your business.