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ISO 13485 Certification - Medical Devices

ISO 13485 Certification - Medical Devices

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

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Reach International regulatory compliance for Medical Devices with ISO 13485

SO 13485 Medical Devices

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

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.

ISO 13485 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 optimize efficiency and minimize costs
ISO 13485 will also help you to monitor your supply chain so that you are always in control

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Is ISO 13485 Certification Right For Our Business?

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.

Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference. Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing.

Further, there are many terms in ISO 13485 unique to medical devices. ISO 13485 also retained the role of a quality representative to top management, where ISO 9001 removed this in many aspects. Interestingly, ISO 9001 has a lot more requirements for monitoring external providers for performance than the old version, and this is something always required by ISO 13485.

Get Started Today with Strider International – Improve Quality & Performance.

Demonstrate your ability to consistently provide products that meet customer and regulatory requirements. Talk with a qualified Strider International representative to learn more about our ISO 13485 certification and how you can benefit from ISO 13485 qualifications!