ISO 13485:2016 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 Business Benefits
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.
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.
Commited 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.
For a free Quotation or On-Site presentation by an ISO Specialist, contact us today!
IMSM New Zealand Ltd.
The AIG Building,
41 Shortland Street,