Blue Life Solutions, a medical device manufacturing company specializing in sample collection devices, has received ISO 13485:2016 certification. The certification serves as a milestone in Blue Life Solutions’ mission to advance disease diagnostics, according to the company

ISO 13485 is a globally recognized standard that symbolizes an organization’s commitment to quality, regulatory compliance, and the implementation of rigorous processes to guarantee the safety and efficacy of medical devices.

“We are thrilled to announce our ISO 13485:2016 certification,” said Tarek Soubra, general manager of Blue Life Solutions. “This milestone represents the culmination of our team’s hard work and dedication to ensuring the utmost quality in our medical devices. It reaffirms our commitment to not only meeting but exceeding the expectations of healthcare providers and the patients they serve.”

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, according to the International Organization for Standardization.

In achieving ISO 13485:2016 certification, the company stated that it will be dedicated to the following principles:

  • Quality assurance: Blue Life Solutions places quality at the forefront of its operations, ensuring that its medical devices consistently meet or exceed industry standards.
  • Regulatory compliance: The company is committed to adhering to all regulatory requirements, ensuring that its products meet the stringent criteria set by regulatory bodies.
  • Patient safety: Blue Life Solutions prioritizes patient safety, designing and manufacturing medical devices with the highest levels of safety in mind.
  • Process excellence: The ISO 13485:2016 certification attests to the company’s implementation of robust processes, ensuring the reliability and consistency of its products.