ISO 13485:2003

Medical Devices

ISO 13485 provides proof that your company is providing safe and effective medical devices

ISO 13485 specifies requirements for a Quality Management System for organisations required to demonstrate its ability to provide medical devices that consistently meet client and regulatory requirements.

ISO 13485 is the most accepted global standard of its kind and will bring your business a host of benefits, including:

    • Full ISO 13485 compliance – which is fast becoming a prerequisite for regulatory authorities everywhere
    • Be confident that your company has a quality system that meets the demands of legislation in every corner of the global market
    • ISO 13485 will establish robust development, manufacture, distribution and control processes
    • The standard will help to optimise efficiency and minimise costs
    • ISO 13485 will also help you to monitor your supply chain so that you are always in control
IMSM strive to make ISO certification as simple as possible for our clients. To find out how trouble-free it really is, take a look at our 5 Simple Steps to ISO Certification.