ISO 13485 2016
ISO 13485 2016 states the requirements for a Quality Management System (QMS), in which organizations will demonstrate their ability to provide devices needed in the medical industry and related services that needs to comply regulatory requirement and customer needs.
This standard can also be used by external parties and suppliers who supply such products and services to those organizations.
Contact us to attain ISO 13485:2016 standard certification to your Organization. Get in touch with us.
How would we help you attain this 13485:2016 QMS for Medical devices?
With the 5 steps approach, the organization can attain the certification in the fastest and most effective way.
- Gain certification to enable your company to increase access to a wider market worldwide
- Plan efficient methods to review and streamline processes in your organization
- Enhance supply chain performance, minimise costs and increase business efficiency
- Able to produce safe and effective medical equipment and devices
- Meet regulatory requirements and customer expectations