ISO 13485:2003

Medical Devices

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

Requirements Guide
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Patient safety is a priority in the healthcare industry

As a medical devices manufacturer, you have a responsibility and requirement to consistently deliver devices that are high quality, safe and effective. The medical device industry is made up of many different and complex regulations, standards and other requirements.

The medical device standard, ISO 13485, helps manufacturers to become compliant and open up market channels on a global scale.

Committed to quality

Achieving an ISO standard demonstrates that your company is serious about delivering quality systems through tested processes. Internally ISO standards provide focus and discipline and externally you will achieve credibility, authority and recognition.

Increase customer confidence, improve customer satisfaction and maintain a market edge; find out more about how your company can achieve ISO 13485 compliance by contacting IMSM today.