ISO 13485:2016

ISO 13485:2016 is an effective solution for meeting the stringent requirements of a quality management system (QMS) related to medical devices. It is a practical foundation for chemical suppliers to meet Medical Device Directives, regulations, and responsibilities, while also demonstrating that they are committed to the safety and quality of medical devices.

Under ISO 13485, businesses must be able to demonstrate their ability to provide medical devices and related services that constantly meet customer and relevant regulatory requirements.

At ReAgent, we take the quality of our products, services, and processes very seriously. We are accredited under ISO 13485 to manufacture in vitro diagnostic reagents for medical devices. This accreditation is underpinned by our Quality Policy which details what we do to manage our quality management system correctly and responsibly.

Benefits of ISO 13485:2016 Accreditation

Holding ISO 13485 accreditation provides many benefits to both ReAgent and our customers, including:

  • International recognition – ISO 13485 is the quality standard in major medical device markets
  • Meeting legal, regulatory, and compliance requirements
  • Improved product safety
  • Increased customer satisfaction – the ISO 13485 QMS focuses on improving customer satisfaction by identifying and meeting customer needs
  • Better integrated processes – looking at how all processes interact means we can identify areas for improvement and resource savings which we can pass on to our customers
  • Creating a culture of continual improvement
  • More effective risk management

If you are looking for a bespoke in vitro diagnostic reagent to use with medical devices, contact our team today.

1-800-817-175